The following data is part of a premarket notification filed by Sofamor Danek Usa,inc. with the FDA for Cd Horizon Spinal System.
| Device ID | K961633 |
| 510k Number | K961633 |
| Device Name: | CD HORIZON 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 | 1996-04-29 |
| Decision Date | 1996-12-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994763815 | K961633 | 000 |
| 00673978063577 | K961633 | 000 |
| 00673978063560 | K961633 | 000 |
| 00673978063553 | K961633 | 000 |
| 00673978063539 | K961633 | 000 |
| 00673978063522 | K961633 | 000 |
| 00673978063515 | K961633 | 000 |
| 00673978063508 | K961633 | 000 |
| 00673978063492 | K961633 | 000 |
| 00673978063478 | K961633 | 000 |
| 00673978063461 | K961633 | 000 |
| 00673978063454 | K961633 | 000 |
| 00673978063447 | K961633 | 000 |
| 00673978063430 | K961633 | 000 |
| 00673978057682 | K961633 | 000 |
| 00673978057590 | K961633 | 000 |
| 00673978063584 | K961633 | 000 |
| 00673978063591 | K961633 | 000 |
| 00673978063607 | K961633 | 000 |
| 00613994763808 | K961633 | 000 |
| 00613994763792 | K961633 | 000 |
| 00613994763754 | K961633 | 000 |
| 00613994763747 | K961633 | 000 |
| 00613994763730 | K961633 | 000 |
| 00613994582744 | K961633 | 000 |
| 00613994549099 | K961633 | 000 |
| 00613994549082 | K961633 | 000 |
| 00613994381415 | K961633 | 000 |
| 00673978156330 | K961633 | 000 |
| 00673978156323 | K961633 | 000 |
| 00673978156316 | K961633 | 000 |
| 00673978096803 | K961633 | 000 |
| 00673978096766 | K961633 | 000 |
| 00673978063614 | K961633 | 000 |
| 00673978026343 | K961633 | 000 |