The following data is part of a premarket notification filed by Depuy Mitek, A Johnson & Johnson Co. with the FDA for Healix Ti Anchor.
| Device ID | K082282 |
| 510k Number | K082282 |
| Device Name: | HEALIX TI ANCHOR |
| Classification | Screw, Fixation, Bone |
| Applicant | DEPUY MITEK, A JOHNSON & JOHNSON CO. 325 Paramount Drive Raynham, MA 02767 |
| Contact | Kristine Christo |
| Correspondent | Kristine Christo DEPUY MITEK, A JOHNSON & JOHNSON CO. 325 Paramount Drive Raynham, MA 02767 |
| Product Code | HWC |
| Subsequent Product Code | JDR |
| Subsequent Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-11 |
| Decision Date | 2008-11-07 |
| Summary: | summary |