The following data is part of a premarket notification filed by Synthes Usa Products, Llc with the FDA for Synapse System, Synthes Oc Fusion System.
| Device ID | K141897 |
| 510k Number | K141897 |
| Device Name: | SYNAPSE SYSTEM, SYNTHES OC FUSION SYSTEM |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | SYNTHES USA PRODUCTS, LLC 325 PARAMOUNT DRIVE Rayham, MA 02767 |
| Contact | Mitch Ohiwa |
| Correspondent | Mitch Ohiwa SYNTHES USA PRODUCTS, LLC 325 PARAMOUNT DRIVE Rayham, MA 02767 |
| Product Code | KWP |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-14 |
| Decision Date | 2014-09-25 |
| Summary: | summary |