The following data is part of a premarket notification filed by Sofamor Danek Usa,inc. with the FDA for Compact Cotrel-dubousset (ccd) Spinal System.
| Device ID | K955365 |
| 510k Number | K955365 |
| Device Name: | COMPACT COTREL-DUBOUSSET (CCD) 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 | 1995-11-22 |
| Decision Date | 1996-03-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00673978157047 | K955365 | 000 |
| 00673978111551 | K955365 | 000 |
| 00673978111544 | K955365 | 000 |
| 00673978096780 | K955365 | 000 |
| 00721902747342 | K955365 | 000 |