The following data is part of a premarket notification filed by Sofamor Danek Usa,inc. with the FDA for Alpha Posterior Spinal System.
| Device ID | K964275 |
| 510k Number | K964275 |
| Device Name: | ALPHA POSTERIOR SPINAL SYSTEM |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | SOFAMOR DANEK USA,INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Richard W Treharne |
| Correspondent | Richard W Treharne SOFAMOR DANEK USA,INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Product Code | KWP |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-25 |
| Decision Date | 1997-01-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994143181 | K964275 | 000 |
| 00721902457920 | K964275 | 000 |
| 00673978037929 | K964275 | 000 |
| 00673978042732 | K964275 | 000 |
| 00673978042749 | K964275 | 000 |
| 00673978042756 | K964275 | 000 |
| 00673978048086 | K964275 | 000 |
| 00673978048710 | K964275 | 000 |
| 00681490844123 | K964275 | 000 |
| 00681490885652 | K964275 | 000 |
| 00681490885669 | K964275 | 000 |
| 00721902457777 | K964275 | 000 |