The following data is part of a premarket notification filed by Synthes Spine with the FDA for Synthes Vectra-one System.
Device ID | K071667 |
510k Number | K071667 |
Device Name: | SYNTHES VECTRA-ONE SYSTEM |
Classification | Appliance, Fixation, Spinal Intervertebral Body |
Applicant | SYNTHES SPINE 1302 WRIGHTS LANE EAST West Chester, PA 19380 |
Contact | Stacey Bonnell |
Correspondent | Stacey Bonnell SYNTHES SPINE 1302 WRIGHTS LANE EAST West Chester, PA 19380 |
Product Code | KWQ |
CFR Regulation Number | 888.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-06-19 |
Decision Date | 2007-11-30 |
Summary: | summary |