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 | K992928 |
| 510k Number | K992928 |
| Device Name: | CD HORIZON SPINAL SYSTEM |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | SOFAMOR DANEK USA,INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Bailey Lipscomb |
| Correspondent | Bailey Lipscomb SOFAMOR DANEK USA,INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Product Code | MNI |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-31 |
| Decision Date | 1999-09-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994152428 | K992928 | 000 |
| 00721902758089 | K992928 | 000 |
| 00721902757921 | K992928 | 000 |
| 00721902757907 | K992928 | 000 |
| 00721902757891 | K992928 | 000 |
| 00721902757815 | K992928 | 000 |
| 00721902757754 | K992928 | 000 |
| 00721902757686 | K992928 | 000 |
| 00721902757617 | K992928 | 000 |
| 00721902757600 | K992928 | 000 |
| 00721902758102 | K992928 | 000 |
| 00721902758188 | K992928 | 000 |
| 00721902758294 | K992928 | 000 |
| 00721902953101 | K992928 | 000 |
| 00721902941498 | K992928 | 000 |
| 00721902831744 | K992928 | 000 |
| 00721902831737 | K992928 | 000 |
| 00721902831713 | K992928 | 000 |
| 00721902831706 | K992928 | 000 |
| 00721902831690 | K992928 | 000 |
| 00721902831683 | K992928 | 000 |
| 00721902771460 | K992928 | 000 |
| 00721902648236 | K992928 | 000 |