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FDA Product Code

FDA Product Code MBI — Clearance Directory

Device Class
Class II
Assigned Panel
Orthopedic
21 CFR Citation
888.3040

510(k) Clearances — 604 records · page 7 of 7

K-Number Device Name Applicant Decision Date Clearance Type Summary
K934327 ARTHREX SUTURE ANCHOR SCREW SYSTEM Arthrex, Inc. 1995-09-15 Traditional PDF ↗
K951565 INNOVASIVE DEVICES ROTATOR CUFF FASTENER Innovasive Devices, Inc. 1995-09-08 Traditional PDF ↗
K953459 ACUFEX TAG ANCHOR Acufex Microsurgical, Inc. 1995-08-23 Traditional PDF ↗
K944831 INNOVASIVE 1.9MM, 2.8MM, 3.5MM, 4.5MM ROC SUTURE BONE FASTENER Innovasive Devices, Inc. 1995-02-01 Traditional PDF ↗

Product code MBI · Class II · Orthopedic. Data: openFDA.