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 |