The following data is part of a premarket notification filed by Sofamor Danek Usa,inc. with the FDA for Cd Spinal System.
| Device ID | K964159 |
| 510k Number | K964159 |
| Device Name: | CD SPINAL SYSTEM |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | SOFAMOR DANEK USA,INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Richard W Treharne, Ph.d. |
| Correspondent | Richard W Treharne, Ph.d. SOFAMOR DANEK USA,INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Product Code | KWP |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-16 |
| Decision Date | 1997-10-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00673978063416 | K964159 | 000 |
| 00673978062761 | K964159 | 000 |
| 00673978062778 | K964159 | 000 |
| 00673978062785 | K964159 | 000 |
| 00673978062792 | K964159 | 000 |
| 00673978062808 | K964159 | 000 |
| 00673978063362 | K964159 | 000 |
| 00673978063379 | K964159 | 000 |
| 00673978063386 | K964159 | 000 |
| 00673978063393 | K964159 | 000 |
| 00673978063409 | K964159 | 000 |
| 00673978062754 | K964159 | 000 |