The following data is part of a premarket notification filed by Synthes Spine Co.lp with the FDA for Synthes Zero-p Variable Angle (va).
| Device ID | K121852 |
| 510k Number | K121852 |
| Device Name: | SYNTHES ZERO-P VARIABLE ANGLE (VA) |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Applicant | SYNTHES SPINE CO.LP 1302 WRIGHTS LANE EAST West Chester, PA 19380 |
| Contact | Monika Mcdole-russell |
| Correspondent | Monika Mcdole-russell 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 | 2012-06-25 |
| Decision Date | 2012-07-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H98104647878S0 | K121852 | 000 |
| H98104647876S0 | K121852 | 000 |
| H98104647874S0 | K121852 | 000 |
| H98104647872S0 | K121852 | 000 |
| H98104647836S0 | K121852 | 000 |
| H98104647834S0 | K121852 | 000 |