The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synapse System 4.0mm, Oc Fusion System 4.0mm.
| Device ID | K091689 |
| 510k Number | K091689 |
| Device Name: | SYNAPSE SYSTEM 4.0MM, OC FUSION SYSTEM 4.0MM |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | SYNTHES (USA) 1302 WRIGHTS LANE EAST West Chester, PA 19380 |
| Contact | Stacey Bonnell |
| Correspondent | Stacey Bonnell SYNTHES (USA) 1302 WRIGHTS LANE EAST West Chester, PA 19380 |
| 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 | 2009-06-10 |
| Decision Date | 2009-07-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H981SD4981350 | K091689 | 000 |
| H981SD4981340 | K091689 | 000 |
| H981SD4981330 | K091689 | 000 |