The following data is part of a premarket notification filed by Osteotech, Inc. with the FDA for Versalink Titanium Rod-to-rod Couplers.
| Device ID | K003384 |
| 510k Number | K003384 |
| Device Name: | VERSALINK TITANIUM ROD-TO-ROD COUPLERS |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | OSTEOTECH, INC. 51 JAMES WAY Eatontown, NJ 07724 |
| Contact | Kim Thurman |
| Correspondent | Kim Thurman OSTEOTECH, INC. 51 JAMES WAY Eatontown, NJ 07724 |
| Product Code | MNH |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-31 |
| Decision Date | 2000-11-24 |