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FDA Product Code

FDA Product Code HWT — Clearance Directory

Device Class
Class I
Assigned Panel
Orthopedic
21 CFR Citation
888.4800

510(k) Clearances — 10 records

K-Number Device Name Applicant Decision Date Clearance Type Summary
K974406 ORTHOPLAN Ortho-Graphics, Inc. 1998-02-18 Traditional PDF ↗
K960685 ORTHODOC PREOPERATIVE PLANNER MODEL 500 Integrated Surgical Systems, Inc. 1997-01-17 Traditional PDF ↗
K894228 KRONNER SPHERICAL CUTTERS Kronner Medical 1990-07-23 Traditional PDF ↗
K870843 SCHULTZ PHALANGEAL COMP TRIAL/METACARPAL COMP TRIA Warsaw Orthopedic, Inc. 1987-05-27 Traditional PDF ↗
K871323 ARTHROSCOPIC MENISCAL SUTURE SYSTEM Orthopedic Systems, Inc. 1987-05-01 Traditional PDF ↗
K830360 3M OSTEOTOMY GUIDE 3M Company 1983-03-01 Traditional PDF ↗
K811205 MOLDED POLYSULFONE TRIAL PROSTHESIS Shannon Group 1981-05-21 Traditional PDF ↗
K781091 KNEE INSTRUMENTATION, CONDYLAR Biomet, Inc. 1978-07-17 Traditional PDF ↗
K771709 WORRELL TRIAL PATELLA Depuy, Inc. 1977-10-06 Traditional PDF ↗
K771710 WORRELL PATELLA TEMPLATE Depuy, Inc. 1977-10-06 Traditional PDF ↗

Product code HWT · Class I · Orthopedic. Data: openFDA.