The following data is part of a premarket notification filed by Sofamor Co. with the FDA for New C-d System For Spinal Surgery.
| Device ID | K873977 |
| 510k Number | K873977 |
| Device Name: | NEW C-D SYSTEM FOR SPINAL SURGERY |
| Classification | Implant, Fixation Device, Spinal |
| Applicant | SOFAMOR CO. ONE STUART PLAZA DONOHUE/LUXOR ROADS Greensburg, PA 15601 |
| Contact | Abraham Glasser |
| Correspondent | Abraham Glasser SOFAMOR CO. ONE STUART PLAZA DONOHUE/LUXOR ROADS Greensburg, PA 15601 |
| Product Code | JDN |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-09-29 |
| Decision Date | 1987-12-07 |