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FDA Product Code

FDA Product Code LRN — Clearance Directory

Device Class
Class II
Assigned Panel
Orthopedic
21 CFR Citation
888.3030

510(k) Clearances — 8 records

K-Number Device Name Applicant Decision Date Clearance Type Summary
K002755 NON-ABSORBING STERNATOMY MONOFILAMENT SUTURE T. Korossurgical Instruments Corp. 2000-12-04 Traditional PDF ↗
K990355 STAINLESS STEEL SOFT SUTURE WIRE Bregma International Trading Company , Ltd. 1999-07-08 Traditional PDF ↗
K971682 J-FX CERCLAGE SYSTEM Johnson & Johnson Professionals, Inc. 1997-06-27 Traditional PDF ↗
K952783 OXBORO-MEDICAL PIN COVERS Oxboro Medical Intl., Inc. 1995-09-15 Traditional PDF ↗
K942603 ORTHOPAEDIC WIRES Acu Med, Inc. 1994-11-09 Traditional PDF ↗
K900926 TROCHANTER CABLE GRIP SYSTEM (ADD'L INDICATIONS) Howmedica Corp. 1990-04-23 Traditional PDF ↗
K892651 SONGER WIRING SYSTEM Danek Medical, Inc. 1989-07-25 Traditional PDF ↗
K864375 TYPE 316L COTTER WIRE Winn Hirsch & Assoc. 1987-05-20 Traditional PDF ↗

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