The following data is part of a premarket notification filed by Depuy Mitek, A Johnson & Johnson Company with the FDA for Versalok Peek Anchor With Orthocord Suture, Models 210818, 210819.
| Device ID | K100532 |
| 510k Number | K100532 |
| Device Name: | VERSALOK PEEK ANCHOR WITH ORTHOCORD SUTURE, MODELS 210818, 210819 |
| Classification | Screw, Fixation, Bone |
| Applicant | DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR. Raynham, MA 02767 |
| Contact | Kristine Christo |
| Correspondent | Kristine Christo DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR. Raynham, MA 02767 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-25 |
| Decision Date | 2010-03-17 |
| Summary: | summary |