The following data is part of a premarket notification filed by Synthes Usa Products Llc with the FDA for Synapse System.
| Device ID | K133698 |
| 510k Number | K133698 |
| Device Name: | SYNAPSE SYSTEM |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | SYNTHES USA PRODUCTS LLC 325 Paramount Drive Raynham, MA 02767 |
| Contact | Laura Bleyendaal |
| Correspondent | Laura Bleyendaal SYNTHES USA PRODUCTS LLC 325 Paramount Drive Raynham, MA 02767 |
| Product Code | KWP |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-03 |
| Decision Date | 2014-01-16 |
| Summary: | summary |