The following data is part of a premarket notification filed by Depuy Miltek, A Johnson & Johnson Co. with the FDA for Panalok Quickanchor Plus, Panalok Rc Quickanchor Plus Dual Suture, Panalok Anchor.
| Device ID | K063273 |
| 510k Number | K063273 |
| Device Name: | PANALOK QUICKANCHOR PLUS, PANALOK RC QUICKANCHOR PLUS DUAL SUTURE, PANALOK ANCHOR |
| Classification | Staple, Fixation, Bone |
| Applicant | DEPUY MILTEK, A JOHNSON & JOHNSON CO. 325 PARAMOUNT DR. Raynham, MA 02767 |
| Contact | Kristine Christo |
| Correspondent | Kristine Christo DEPUY MILTEK, A JOHNSON & JOHNSON CO. 325 PARAMOUNT DR. Raynham, MA 02767 |
| Product Code | JDR |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-10-30 |
| Decision Date | 2006-11-22 |
| Summary: | summary |