The following data is part of a premarket notification filed by Depuy Mitek, A Johnson & Johnson Company with the FDA for Gryphon T Br Ds Anchor W/orthocord, Gryphon T Br Anchor W /orthocord, Gryphon P Br Ds Anchor W/orthocord, Gryphon P Br A.
| Device ID | K100012 |
| 510k Number | K100012 |
| Device Name: | GRYPHON T BR DS ANCHOR W/ORTHOCORD, GRYPHON T BR ANCHOR W /ORTHOCORD, GRYPHON P BR DS ANCHOR W/ORTHOCORD, GRYPHON P BR A |
| 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 | 2010-01-04 |
| Decision Date | 2010-04-30 |
| Summary: | summary |