The following data is part of a premarket notification filed by Alphatec Spine, Inc. with the FDA for Zodiac Adjustable Bridges, Models 11-20xx,11-25xx,11-30xx,11-35xx.
Device ID | K061321 |
510k Number | K061321 |
Device Name: | ZODIAC ADJUSTABLE BRIDGES, MODELS 11-20XX,11-25XX,11-30XX,11-35XX |
Classification | Orthosis, Spondylolisthesis Spinal Fixation |
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 | MNH |
Subsequent Product Code | KWP |
Subsequent Product Code | MNI |
CFR Regulation Number | 888.3070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-05-11 |
Decision Date | 2006-07-07 |
Summary: | summary |