Device Classification Name |
Fastener, Fixation, Biodegradable, Soft Tissue
|
510(k) Number |
K073412 |
Device Name |
GRYPHON BR AND HEALIX BR ANCHORS |
Applicant |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
325 PARAMOUNT DR. |
RAYNHAM,
MA
02767
|
|
Applicant Contact |
Ruth Forstadt |
Correspondent |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
325 PARAMOUNT DR. |
RAYNHAM,
MA
02767
|
|
Correspondent Contact |
Ruth Forstadt |
Regulation Number | 888.3030
|
Classification Product Code |
|
Date Received | 12/04/2007 |
Decision Date | 01/17/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|