The following data is part of a premarket notification filed by Osteonics Corp. with the FDA for Osteonics Spinal System - Variable Offset Connector Assembly.
| Device ID | K964544 |
| 510k Number | K964544 |
| Device Name: | OSTEONICS SPINAL SYSTEM - VARIABLE OFFSET CONNECTOR ASSEMBLY |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677 |
| Contact | Donna S Wilson |
| Correspondent | Donna S Wilson OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677 |
| Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-13 |
| Decision Date | 1997-02-11 |
| Summary: | summary |