The following data is part of a premarket notification filed by Alphatec Mfg., Inc. with the FDA for Alphatec 2.7 Mm Cannulated Cortical Lag Screw.
Device ID | K923256 |
510k Number | K923256 |
Device Name: | ALPHATEC 2.7 MM CANNULATED CORTICAL LAG SCREW |
Classification | Screw, Fixation, Bone |
Applicant | ALPHATEC MFG., INC. 42-160 STATE ST. Palm Desert, CA 92211 -5148 |
Contact | Thomas A Hoghaug |
Correspondent | Thomas A Hoghaug ALPHATEC MFG., INC. 42-160 STATE ST. Palm Desert, CA 92211 -5148 |
Product Code | HWC |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-07-02 |
Decision Date | 1992-10-09 |