510(k) Premarket Notification Database
Device Classification Name |
appliance, fixation, spinal interlaminal
|
510(k) Number | K070638 |
Device Name | THEKEN ATOLL CERVICO-THORACIC SYSTEM |
Applicant |
THEKEN SPINE LLC
|
283 e waterloo rd. |
akron,
OH
44319 |
|
Contact | dale davison |
Regulation Number | 888.3050 |
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/07/2007 |
Decision Date | 05/30/2007 |
Decision |
substantially equivalent (SE) |
Classification Advisory Committee |
Orthopedic
|
Review Advisory Committee |
Orthopedic
|
Statement/Summary/Purged Status |
Summary only
|
summary |
summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Expedited Review |
No
|
|
|