The following data is part of a premarket notification filed by Synthes Spine with the FDA for Synthes Zero-p.
| Device ID | K093762 |
| 510k Number | K093762 |
| Device Name: | SYNTHES ZERO-P |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Applicant | SYNTHES SPINE 1302 WRIGHTS LANE EAST West Chester, PA 19380 |
| Contact | Amnon Talmor |
| Correspondent | Amnon Talmor SYNTHES SPINE 1302 WRIGHTS LANE EAST West Chester, PA 19380 |
| Product Code | OVE |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-07 |
| Decision Date | 2010-12-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H981SD036179620 | K093762 | 000 |