The following data is part of a premarket notification filed by Depuy Synthes, Inc. with the FDA for Summit Si Oct Spinal Fixation System, Mountaineer Oct Spinal System.
| Device ID | K151885 |
| 510k Number | K151885 |
| Device Name: | SUMMIT SI OCT Spinal Fixation System, MOUNTAINEER OCT Spinal System |
| Classification | Posterior Cervical Screw System |
| Applicant | DEPUY SYNTHES, Inc. 325 Paramount Drive Raynham, MA 02767 |
| Contact | Karen K Sylvia |
| Correspondent | Laura Bleyendaal DePuy Synthes 325 Paramount Drive Raynham, MA 02767 |
| Product Code | NKG |
| CFR Regulation Number | 888.3075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-09 |
| Decision Date | 2015-09-03 |
| Summary: | summary |