The following data is part of a premarket notification filed by Alphatec Mfg., Inc. with the FDA for Alphatec 130-150 Slotted Compression Hip Screw.
Device ID | K926417 |
510k Number | K926417 |
Device Name: | ALPHATEC 130-150 SLOTTED COMPRESSION HIP SCREW |
Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
Applicant | ALPHATEC MFG., INC. 42-160 STATE ST. Palm Desert, CA 92211 -5148 |
Contact | Bradford D Davis |
Correspondent | Bradford D Davis ALPHATEC MFG., INC. 42-160 STATE ST. Palm Desert, CA 92211 -5148 |
Product Code | KTT |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-12-23 |
Decision Date | 1994-09-28 |