The following data is part of a premarket notification filed by Depuy Mitek with the FDA for Healix Advance Peek Anchor.
| Device ID | K120449 |
| 510k Number | K120449 |
| Device Name: | HEALIX ADVANCE PEEK ANCHOR |
| Classification | Screw, Fixation, Bone |
| Applicant | Depuy Mitek 325 Paramount Drive Raynham, MA 02767 |
| Contact | Yayoi Fujimaki |
| Correspondent | Yayoi Fujimaki Depuy Mitek 325 Paramount Drive Raynham, MA 02767 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-14 |
| Decision Date | 2012-05-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20886705021540 | K120449 | 000 |
| 10886705021406 | K120449 | 000 |
| 10886705021413 | K120449 | 000 |
| 10886705021420 | K120449 | 000 |
| 10886705021437 | K120449 | 000 |
| 10886705021444 | K120449 | 000 |
| 10886705021451 | K120449 | 000 |
| 10886705021468 | K120449 | 000 |
| 20886705021496 | K120449 | 000 |
| 20886705021502 | K120449 | 000 |
| 20886705021533 | K120449 | 000 |
| 10886705021390 | K120449 | 000 |