The following data is part of a premarket notification filed by Depuy Mitek Inc., Johnson And Johnson Company with the FDA for Healix Advance Br Anchor.
| Device ID | K120078 |
| 510k Number | K120078 |
| Device Name: | HEALIX ADVANCE BR ANCHOR |
| Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
| Applicant | DEPUY MITEK INC., JOHNSON AND JOHNSON COMPANY 325 Paramount Drive Raynham, MA 02767 |
| Contact | Yayoi Fujimaki |
| Correspondent | Yayoi Fujimaki DEPUY MITEK INC., 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 | 2012-01-10 |
| Decision Date | 2012-02-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20886705021526 | K120078 | 000 |
| 10886705021321 | K120078 | 000 |
| 10886705021338 | K120078 | 000 |
| 10886705021345 | K120078 | 000 |
| 10886705021352 | K120078 | 000 |
| 10886705021369 | K120078 | 000 |
| 10886705021376 | K120078 | 000 |
| 10886705021383 | K120078 | 000 |
| 20886705021472 | K120078 | 000 |
| 20886705021489 | K120078 | 000 |
| 20886705021519 | K120078 | 000 |
| 10886705021314 | K120078 | 000 |