The following data is part of a premarket notification filed by Depuy Mitek, A Johnson And Johnson Company with the FDA for Gryphon Br Anchor W/proknot Technology,gryphon Peek Anchor W/ Proknot Technology.
| Device ID | K140643 |
| 510k Number | K140643 |
| Device Name: | GRYPHON BR ANCHOR W/PROKNOT TECHNOLOGY,GRYPHON PEEK ANCHOR W/ PROKNOT TECHNOLOGY |
| Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
| Applicant | DEPUY MITEK, A JOHNSON AND JOHNSON COMPANY 325 Paramount Drive Raynham, MA 02767 |
| Contact | Yayoi Fujimaki |
| Correspondent | Yayoi Fujimaki DEPUY MITEK, A JOHNSON AND JOHNSON COMPANY 325 Paramount Drive 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 | 2014-03-12 |
| Decision Date | 2014-07-08 |
| Summary: | summary |