The following data is part of a premarket notification filed by Depuy Mitek, A Johnson & Johnson Company with the FDA for Healix Knotless Anchor.
| Device ID | K113534 |
| 510k Number | K113534 |
| Device Name: | HEALIX KNOTLESS ANCHOR |
| Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
| Applicant | DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR. Raynham, MA 02767 |
| Contact | Deep Pal |
| Correspondent | Deep Pal 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-30 |
| Decision Date | 2011-12-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10886705020393 | K113534 | 000 |