The following data is part of a premarket notification filed by Alphatec Spine, Inc. with the FDA for Arsenal Spinal Fixation System.
Device ID | K133221 |
510k Number | K133221 |
Device Name: | ARSENAL SPINAL FIXATION SYSTEM |
Classification | Thoracolumbosacral Pedicle Screw System |
Applicant | ALPHATEC SPINE, INC. 5830 EL CAMINO REAL Carlsbad, CA 92008 |
Contact | Renee L Murphy |
Correspondent | Renee L Murphy ALPHATEC SPINE, INC. 5830 EL CAMINO REAL Carlsbad, CA 92008 |
Product Code | NKB |
Subsequent Product Code | MNH |
Subsequent Product Code | MNI |
Subsequent Product Code | OSH |
CFR Regulation Number | 888.3070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-10-18 |
Decision Date | 2014-03-13 |
Summary: | summary |