The following data is part of a premarket notification filed by Synthes Spine with the FDA for Synthes Synapse Transconnector.
| Device ID | K090549 |
| 510k Number | K090549 |
| Device Name: | SYNTHES SYNAPSE TRANSCONNECTOR |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | SYNTHES SPINE 1302 WRIGHTS LANE EAST West Chester, PA 19380 |
| Contact | Stacey Bonnell |
| Correspondent | Stacey Bonnell SYNTHES SPINE 1302 WRIGHTS LANE EAST West Chester, PA 19380 |
| Product Code | KWP |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-02 |
| Decision Date | 2009-05-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H981046145200 | K090549 | 000 |