The following data is part of a premarket notification filed by Synthes Usa Products, Llc with the FDA for Synapse Occipital-cervical-thoracic (oct) System.
| Device ID | K142838 |
| 510k Number | K142838 |
| Device Name: | Synapse Occipital-Cervical-Thoracic (OCT) System |
| Classification | Posterior Cervical Screw System |
| Applicant | SYNTHES USA PRODUCTS, LLC 325 PARAMOUNT DRIVE Raynham, MA 02767 |
| Contact | Kate Larose |
| Correspondent | Kate Larose SYNTHES USA PRODUCTS, LLC 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 | 2014-09-30 |
| Decision Date | 2015-01-20 |
| Summary: | summary |