The following data is part of a premarket notification filed by Synthes Spine Co.lp with the FDA for Synthes Zero-p.
| Device ID | K112459 |
| 510k Number | K112459 |
| Device Name: | SYNTHES ZERO-P |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Applicant | SYNTHES SPINE CO.LP 1302 WRIGHTS LANE EAST West Chester, PA 19380 |
| Contact | Stacey Bonnell |
| Correspondent | Stacey Bonnell SYNTHES SPINE CO.LP 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 | 2011-08-26 |
| Decision Date | 2011-12-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H981036177300 | K112459 | 000 |
| H981036177670 | K112459 | 000 |
| H981036177680 | K112459 | 000 |
| H981036177690 | K112459 | 000 |
| H981036177900 | K112459 | 000 |
| H981036177910 | K112459 | 000 |
| H981036177960 | K112459 | 000 |
| H981036177970 | K112459 | 000 |
| H981036177980 | K112459 | 000 |
| H981036177990 | K112459 | 000 |
| H981036177660 | K112459 | 000 |
| H981036177650 | K112459 | 000 |
| H981036177310 | K112459 | 000 |
| H981036177350 | K112459 | 000 |
| H981036177360 | K112459 | 000 |
| H981036177370 | K112459 | 000 |
| H981036177380 | K112459 | 000 |
| H981036177390 | K112459 | 000 |
| H981036177600 | K112459 | 000 |
| H981036177610 | K112459 | 000 |
| H981036177620 | K112459 | 000 |
| H98104617210S0 | K112459 | 000 |
| H98104617211S0 | K112459 | 000 |
| H98104617212S0 | K112459 | 000 |
| H98104617228S0 | K112459 | 000 |
| H98104617229S0 | K112459 | 000 |
| H98104617230S0 | K112459 | 000 |
| H98104617231S0 | K112459 | 000 |
| H98104617232S0 | K112459 | 000 |
| H98104617235S0 | K112459 | 000 |
| H98104617236S0 | K112459 | 000 |
| H98104617237S0 | K112459 | 000 |
| H98104617238S0 | K112459 | 000 |
| H98104617227S0 | K112459 | 000 |
| H98104617226S0 | K112459 | 000 |
| H98104617215S0 | K112459 | 000 |
| H98104617216S0 | K112459 | 000 |
| H98104617217S0 | K112459 | 000 |
| H98104617218S0 | K112459 | 000 |
| H98104617219S0 | K112459 | 000 |
| H98104617220S0 | K112459 | 000 |
| H98104617221S0 | K112459 | 000 |
| H98104617222S0 | K112459 | 000 |
| H98104617225S0 | K112459 | 000 |
| H98104617239S0 | K112459 | 000 |