The following data is part of a premarket notification filed by Alphatec Spine, Inc. with the FDA for Solanas Posterior Stabilization System.
Device ID | K131119 |
510k Number | K131119 |
Device Name: | SOLANAS POSTERIOR STABILIZATION SYSTEM |
Classification | Thoracolumbosacral Pedicle Screw System |
Applicant | ALPHATEC SPINE, INC. 5818 EL CAMINO REAL Carlsbad, CA 92008 |
Contact | Trevor Denbo |
Correspondent | Trevor Denbo ALPHATEC SPINE, INC. 5818 EL CAMINO REAL Carlsbad, CA 92008 |
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 | 2013-04-22 |
Decision Date | 2013-05-21 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00844856064249 | K131119 | 000 |
00844856064232 | K131119 | 000 |