The following data is part of a premarket notification filed by Alphatec Spine, Inc. with the FDA for Next Generation Anterior Cervical Plating System.
Device ID | K070681 |
510k Number | K070681 |
Device Name: | NEXT GENERATION ANTERIOR CERVICAL PLATING SYSTEM |
Classification | Appliance, Fixation, Spinal Intervertebral Body |
Applicant | ALPHATEC SPINE, INC. 2051 PALOMAR AIRPORT ROAD SUITE 100 Carlsbad, CA 92011 |
Contact | Paula Morgan |
Correspondent | Paula Morgan ALPHATEC SPINE, INC. 2051 PALOMAR AIRPORT ROAD SUITE 100 Carlsbad, CA 92011 |
Product Code | KWQ |
CFR Regulation Number | 888.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-03-12 |
Decision Date | 2007-05-04 |
Summary: | summary |