The following data is part of a premarket notification filed by Osteotech, Inc. with the FDA for Osteotech Navicular And Cancellous Cannulated Screws.
| Device ID | K950652 |
| 510k Number | K950652 |
| Device Name: | OSTEOTECH NAVICULAR AND CANCELLOUS CANNULATED SCREWS |
| Classification | Screw, Fixation, Bone |
| Applicant | OSTEOTECH, INC. 1151 SHREWSBURY AVE. Shrewsbury, NJ 07702 |
| Contact | Cjristopher Talbot |
| Correspondent | Cjristopher Talbot OSTEOTECH, INC. 1151 SHREWSBURY AVE. Shrewsbury, NJ 07702 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-13 |
| Decision Date | 1995-06-22 |