The following data is part of a premarket notification filed by Alphatec Spine, Inc. with the FDA for Modification To Solanas Posterior Stabilization System.
Device ID | K071380 |
510k Number | K071380 |
Device Name: | MODIFICATION TO SOLANAS POSTERIOR STABILIZATION SYSTEM |
Classification | Thoracolumbosacral Pedicle Screw System |
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 | NKB |
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 | 2007-05-17 |
Decision Date | 2007-08-20 |
Summary: | summary |