The following data is part of a premarket notification filed by Osteotech, Inc. with the FDA for Versalok Low Back Fixation System.
| Device ID | K992885 |
| 510k Number | K992885 |
| Device Name: | VERSALOK LOW BACK FIXATION SYSTEM |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | OSTEOTECH, INC. 51 JAMES WAY Eatontown, NJ 07724 |
| Contact | Jing Zhang |
| Correspondent | Jing Zhang OSTEOTECH, INC. 51 JAMES WAY Eatontown, NJ 07724 |
| Product Code | KWP |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-27 |
| Decision Date | 1999-11-19 |
| Summary: | summary |