The following data is part of a premarket notification filed by Osteonics Corp. with the FDA for Osteonics Spinal System - Sacral Offset Connector Assembly.
| Device ID | K984375 |
| 510k Number | K984375 |
| Device Name: | OSTEONICS SPINAL SYSTEM - SACRAL OFFSET CONNECTOR ASSEMBLY |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677 |
| Contact | Marybeth Naughton |
| Correspondent | Marybeth Naughton OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677 |
| 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 | 1998-12-07 |
| Decision Date | 1999-04-30 |
| Summary: | summary |