The following data is part of a premarket notification filed by Depuy Mitek, A Johnson & Johnson Company with the FDA for Versalok Anchor With Free Strands Of Orthocord Suture (210808), Ethibond Suture (210809), And Panacryl Suture (210810).
| Device ID | K063478 |
| 510k Number | K063478 |
| Device Name: | VERSALOK ANCHOR WITH FREE STRANDS OF ORTHOCORD SUTURE (210808), ETHIBOND SUTURE (210809), AND PANACRYL SUTURE (210810) |
| Classification | Screw, Fixation, Bone |
| Applicant | DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR. Raynham, MA 02767 |
| Contact | Ruth C Fostadt |
| Correspondent | Ruth C Fostadt DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR. Raynham, MA 02767 |
| Product Code | HWC |
| Subsequent Product Code | GAM |
| Subsequent Product Code | GAS |
| Subsequent Product Code | GAT |
| Subsequent Product Code | MBI |
| Subsequent Product Code | NEW |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-17 |
| Decision Date | 2006-12-15 |
| Summary: | summary |