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FDA Product Code

FDA Product Code NDF — Clearance Directory

Device Class
Class II
Assigned Panel
Orthopedic
21 CFR Citation
888.3030

510(k) Clearances — 3 records

K-Number Device Name Applicant Decision Date Clearance Type Summary
K051642 FR.O.H. CALCANEUS REPAIR SYSTEM I.T.S. Implantat-Technologie-Systeme GmbH 2005-08-22 Traditional PDF ↗
K021749 EBI DYNAFIX VS OSTEOTOMY SYSTEM Ebi, L.P. 2002-08-12 Traditional PDF ↗
K010551 EBI DYNAFIX VS OSTEOTOMY SYSTEM Ebi, L.P. 2001-05-17 Traditional PDF ↗

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