The following data is part of a premarket notification filed by Depuy Mitek, A Johnson & Johnson Company with the FDA for Gryphon Br And Healix Br Anchors.
| Device ID | K073412 |
| 510k Number | K073412 |
| Device Name: | GRYPHON BR AND HEALIX BR ANCHORS |
| Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
| Applicant | DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR. Raynham, MA 02767 |
| Contact | Ruth Forstadt |
| Correspondent | Ruth Forstadt DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR. Raynham, MA 02767 |
| Product Code | MAI |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-04 |
| Decision Date | 2008-01-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10886705024834 | K073412 | 000 |
| 10886705001262 | K073412 | 000 |
| 10886705007769 | K073412 | 000 |
| 10886705007783 | K073412 | 000 |
| 10886705007790 | K073412 | 000 |
| 10886705007844 | K073412 | 000 |
| 10886705007851 | K073412 | 000 |
| 10886705024674 | K073412 | 000 |
| 10886705024681 | K073412 | 000 |
| 10886705024735 | K073412 | 000 |
| 10886705024759 | K073412 | 000 |
| 10886705024766 | K073412 | 000 |
| 10886705024773 | K073412 | 000 |
| 10886705024780 | K073412 | 000 |
| 10886705024797 | K073412 | 000 |
| 10886705024803 | K073412 | 000 |
| 10886705024810 | K073412 | 000 |
| 10886705024827 | K073412 | 000 |
| 10886705001255 | K073412 | 000 |