The following data is part of a premarket notification filed by Osteotech, Inc. with the FDA for Sscs (segmental Spinal Correction System).
| Device ID | K971289 |
| 510k Number | K971289 |
| Device Name: | SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM) |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | OSTEOTECH, INC. 51 JAMES WAY Eatontown, NJ 07724 |
| Contact | Christopher Talbot |
| Correspondent | Christopher Talbot OSTEOTECH, INC. 51 JAMES WAY Eatontown, NJ 07724 |
| Product Code | KWP |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-07 |
| Decision Date | 1997-06-18 |
| Summary: | summary |