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 |