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Title 21--Food and Drugs
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
PART 888--ORTHOPEDIC DEVICES
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 | 888.1 | Scope. |
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| 888.3 | Effective dates of requirement for premarket approval. |
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| 888.5 | Resurfacing technique. |
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| 888.6 | Degree of constraint. |
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| 888.9 | Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). |
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| 888.1100 | Arthroscope. |
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| 888.1240 | AC-powered dynamometer. |
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| 888.1250 | Nonpowered dynamometer. |
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| 888.1500 | Goniometer. |
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| 888.1520 | Nonpowered goniometer. |
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| 888.3000 | Bone cap. |
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| 888.3010 | Bone fixation cerclage. |
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| 888.3015 | Bone heterograft. |
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| 888.3020 | Intramedullary fixation rod. |
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| 888.3025 | Passive tendon prosthesis. |
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| 888.3027 | Polymethylmethacrylate (PMMA) bone cement. |
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| 888.3030 | Single/multiple component metallic bone fixation appliances and accessories. |
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| 888.3040 | Smooth or threaded metallic bone fixation fastener. |
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| 888.3050 | Spinal interlaminal fixation orthosis. |
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| 888.3060 | Spinal intervertebral body fixation orthosis. |
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| 888.3070 | Pedicle screw spinal system. |
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| 888.3100 | Ankle joint metal/composite semi-constrained cemented prosthesis. |
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| 888.3110 | Ankle joint metal/polymer semi-constrained cemented prosthesis. |
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| 888.3120 | Ankle joint metal/polymer non-constrained cemented prosthesis. |
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| 888.3150 | Elbow joint metal/polymer constrained cemented prosthesis. |
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| 888.3160 | Elbow joint metal/polymer semi-constrained cemented prosthesis. |
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| 888.3170 | Elbow joint radial (hemi-elbow) polymer prosthesis. |
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| 888.3180 | Elbow joint humeral (hemi-elbow) metallic uncemented prosthesis. |
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| 888.3200 | Finger joint metal/metal constrained uncemented prosthesis. |
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| 888.3210 | Finger joint metal/metal constrained cemented prosthesis. |
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| 888.3220 | Finger joint metal/polymer constrained cemented prosthesis. |
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| 888.3230 | Finger joint polymer constrained prosthesis. |
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| 888.3300 | Hip joint metal constrained cemented or uncemented prosthesis. |
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| 888.3310 | Hip joint metal/polymer constrained cemented or uncemented prosthesis. |
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| 888.3320 | Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis. |
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| 888.3330 | Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis. |
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| 888.3340 | Hip joint metal/composite semi-constrained cemented prosthesis. |
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| 888.3350 | Hip joint metal/polymer semi-constrained cemented prosthesis. |
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| 888.3353 | Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis. |
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| 888.3358 | Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis. |
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| 888.3360 | Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis. |
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| 888.3370 | Hip joint (hemi-hip) acetabular metal cemented prosthesis. |
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| 888.3380 | Hip joint femoral (hemi-hip) trunnion-bearing metal/polyacetal cemented prosthesis. |
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| 888.3390 | Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis. |
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| 888.3400 | Hip joint femoral (hemi-hip) metallic resurfacing prosthesis. |
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| 888.3410 | Hip joint metal/polymer semi-constrained resurfacing cemented prosthesis. |
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| 888.3480 | Knee joint femorotibial metallic constrained cemented prosthesis. |
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| 888.3490 | Knee joint femorotibial metal/composite non-constrained cemented prosthesis. |
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| 888.3500 | Knee joint femorotibial metal/composite semi-constrained cemented prosthesis. |
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| 888.3510 | Knee joint femorotibial metal/polymer constrained cemented prosthesis. |
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| 888.3520 | Knee joint femorotibial metal/polymer non-constrained cemented prosthesis. |
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| 888.3530 | Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis. |
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| 888.3535 | Knee joint femorotibial (uni-compartmental) metal/polymer porous-coated uncemented prosthesis. |
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| 888.3540 | Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis. |
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| 888.3550 | Knee joint patellofemorotibial polymer/metal/metal constrained cemented prosthesis. |
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| 888.3560 | Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis. |
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| 888.3565 | Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis. |
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| 888.3570 | Knee joint femoral (hemi-knee) metallic uncemented prosthesis. |
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| 888.3580 | Knee joint patellar (hemi-knee) metallic resurfacing uncemented prosthesis. |
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| 888.3590 | Knee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis. |
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| 888.3640 | Shoulder joint metal/metal or metal/polymer constrained cemented prosthesis. |
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| 888.3650 | Shoulder joint metal/polymer non-constrained cemented prosthesis. |
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| 888.3660 | Shoulder joint metal/polymer semi-constrained cemented prosthesis. |
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| 888.3670 | Shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis. |
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| 888.3680 | Shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis. |
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| 888.3690 | Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis. |
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| 888.3720 | Toe joint polymer constrained prosthesis. |
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| 888.3730 | Toe joint phalangeal (hemi-toe) polymer prosthesis. |
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| 888.3750 | Wrist joint carpal lunate polymer prosthesis. |
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| 888.3760 | Wrist joint carpal scaphoid polymer prosthesis. |
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| 888.3770 | Wrist joint carpal trapezium polymer prosthesis. |
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| 888.3780 | Wrist joint polymer constrained prosthesis. |
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| 888.3790 | Wrist joint metal constrained cemented prosthesis. |
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| 888.3800 | Wrist joint metal/polymer semi-constrained cemented prosthesis. |
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| 888.3810 | Wrist joint ulnar (hemi-wrist) polymer prosthesis. |
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| 888.4150 | Calipers for clinical use. |
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| 888.4200 | Cement dispenser. |
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| 888.4210 | Cement mixer for clinical use. |
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| 888.4220 | Cement monomer vapor evacuator. |
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| 888.4230 | Cement ventilation tube. |
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| 888.4300 | Depth gauge for clinical use. |
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| 888.4540 | Orthopedic manual surgical instrument. |
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| 888.4580 | Sonic surgical instrument and accessories/attachments. |
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| 888.4600 | Protractor for clinical use. |
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| 888.4800 | Template for clinical use. |
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| 888.5850 | Nonpowered orthopedic traction apparatus and accessories. |
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| 888.5890 | Noninvasive traction component. |
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| 888.5940 | Cast component. |
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| 888.5960 | Cast removal instrument. |
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| 888.5980 | Manual cast application and removal instrument. |
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