The following data is part of a premarket notification filed by Sofamor Danek Usa,inc. with the FDA for Cotrel-dubousset (cd) Spinal.
| Device ID | K955807 |
| 510k Number | K955807 |
| Device Name: | COTREL-DUBOUSSET (CD) SPINAL |
| 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 For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-22 |
| Decision Date | 1996-10-01 |
| Summary: | summary |