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TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
Subpart A--General Provisions
§ 888.1 - Scope.
§ 888.3 - Effective dates of requirement for premarket approval.
§ 888.5 - Resurfacing technique.
§ 888.6 - Degree of constraint.
§ 888.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
Subpart B--Diagnostic Devices
§ 888.1100 - Arthroscope.
§ 888.1240 - AC-powered dynamometer.
§ 888.1250 - Nonpowered dynamometer.
§ 888.1500 - Goniometer.
§ 888.1520 - Nonpowered goniometer.
Subpart C [Reserved]
Subpart D--Prosthetic Devices
§ 888.3000 - Bone cap.
§ 888.3010 - Bone fixation cerclage.
§ 888.3015 - Bone heterograft.
§ 888.3020 - Intramedullary fixation rod.
§ 888.3025 - Passive tendon prosthesis.
§ 888.3027 - Polymethylmethacrylate (PMMA) bone cement.
§ 888.3030 - Single/multiple component metallic bone fixation appliances and accessories.
§ 888.3040 - Smooth or threaded metallic bone fixation fastener.
§ 888.3045 - Resorbable calcium salt bone void filler device.
§ 888.3050 - Spinal interlaminal fixation orthosis.
§ 888.3060 - Spinal intervertebral body fixation orthosis.
§ 888.3070 - Pedicle screw spinal system.
§ 888.3080 - Intervertebral body fusion device.
§ 888.3100 - Ankle joint metal/composite semi-constrained cemented prosthesis.
§ 888.3110 - Ankle joint metal/polymer semi-constrained cemented prosthesis.
§ 888.3120 - Ankle joint metal/polymer non-constrained cemented prosthesis.
§ 888.3150 - Elbow joint metal/polymer constrained cemented prosthesis.
§ 888.3160 - Elbow joint metal/polymer semi-constrained cemented prosthesis.
§ 888.3170 - Elbow joint radial (hemi-elbow) polymer prosthesis.
§ 888.3180 - Elbow joint humeral (hemi-elbow) metallic uncemented prosthesis.
§ 888.3200 - Finger joint metal/metal constrained uncemented prosthesis.
§ 888.3210 - Finger joint metal/metal constrained cemented prosthesis.
§ 888.3220 - Finger joint metal/polymer constrained cemented prosthesis.
§ 888.3230 - Finger joint polymer constrained prosthesis.
§ 888.3300 - Hip joint metal constrained cemented or uncemented prosthesis.
§ 888.3310 - Hip joint metal/polymer constrained cemented or uncemented prosthesis.
§ 888.3320 - Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis.
§ 888.3330 - Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.
§ 888.3340 - Hip joint metal/composite semi-constrained cemented prosthesis.
§ 888.3350 - Hip joint metal/polymer semi-constrained cemented prosthesis.
§ 888.3353 - Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
§ 888.3358 - Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
§ 888.3360 - Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
§ 888.3370 - Hip joint (hemi-hip) acetabular metal cemented prosthesis.
§ 888.3380 - Hip joint femoral (hemi-hip) trunnion-bearing metal/polyacetal cemented prosthesis.
§ 888.3390 - Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.
§ 888.3400 - Hip joint femoral (hemi-hip) metallic resurfacing prosthesis.
§ 888.3410 - Hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prosthesis.
§ 888.3480 - Knee joint femorotibial metallic constrained cemented prosthesis.
§ 888.3490 - Knee joint femorotibial metal/composite non-constrained cemented prosthesis.
§ 888.3500 - Knee joint femorotibial metal/composite semi-constrained cemented prosthesis.
§ 888.3510 - Knee joint femorotibial metal/polymer constrained cemented prosthesis.
§ 888.3520 - Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.
§ 888.3530 - Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis.
§ 888.3535 - Knee joint femorotibial (uni-compartmental) metal/polymer porous-coated uncemented prosthesis.
§ 888.3540 - Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis.
§ 888.3550 - Knee joint patellofemorotibial polymer/metal/metal constrained cemented prosthesis.
§ 888.3560 - Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
§ 888.3565 - Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
§ 888.3570 - Knee joint femoral (hemi-knee) metallic uncemented prosthesis.
§ 888.3580 - Knee joint patellar (hemi-knee) metallic resurfacing uncemented prosthesis.
§ 888.3590 - Knee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis.
§ 888.3640 - Shoulder joint metal/metal or metal/polymer constrained cemented prosthesis.
§ 888.3650 - Shoulder joint metal/polymer non-constrained cemented prosthesis.
§ 888.3660 - Shoulder joint metal/polymer semi-constrained cemented prosthesis.
§ 888.3670 - Shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis.
§ 888.3680 - Shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis.
§ 888.3690 - Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.
§ 888.3720 - Toe joint polymer constrained prosthesis.
§ 888.3730 - Toe joint phalangeal (hemi-toe) polymer prosthesis.
§ 888.3750 - Wrist joint carpal lunate polymer prosthesis.
§ 888.3760 - Wrist joint carpal scaphoid polymer prosthesis.
§ 888.3770 - Wrist joint carpal trapezium polymer prosthesis.
§ 888.3780 - Wrist joint polymer constrained prosthesis.
§ 888.3790 - Wrist joint metal constrained cemented prosthesis.
§ 888.3800 - Wrist joint metal/polymer semi-constrained cemented prosthesis.
§ 888.3810 - Wrist joint ulnar (hemi-wrist) polymer prosthesis.
Subpart E--Surgical Devices
§ 888.4150 - Calipers for clinical use.
§ 888.4200 - Cement dispenser.
§ 888.4210 - Cement mixer for clinical use.
§ 888.4220 - Cement monomer vapor evacuator.
§ 888.4230 - Cement ventilation tube.
§ 888.4300 - Depth gauge for clinical use.
§ 888.4540 - Orthopedic manual surgical instrument.
§ 888.4580 - Sonic surgical instrument and accessories/attachments.
§ 888.4600 - Protractor for clinical use.
§ 888.4800 - Template for clinical use.
§ 888.5850 - Nonpowered orthopedic traction apparatus and accessories.
§ 888.5890 - Noninvasive traction component.
§ 888.5940 - Cast component.
§ 888.5960 - Cast removal instrument.
§ 888.5980 - Manual cast application and removal instrument.
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