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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: 3.0 DRIVE SHFT FOR QUICKFIX SCREW SYSTEM; BONE-TENDON-BONE GRAFT INSERTER; CANNULATED COUNTERSINK, 4.5MM; CANNULATED COUNTERSINK, 6.7MM; CONSTANT PCL GUIDE DRILL SLEEVE, 3.5MM; GUIDE PIN, 2.4MM ZEBRA; GUIDE SLEEVE, 3MM TRANSFIX II; IBAL TKA,EM ALIGNMNT GD WO SPIKE; IBALANCE TKA, UNIVERSAL IMPACTOR HANDLE; MEDIAL PORTAL, MARKING HOOK ARM, 10MM; MEDIAL PORTAL, MARKING HOOK ARM, 6MM; MEDIAL PORTAL, MARKING HOOK ARM, 7MM; MEDIAL PORTAL, MARKING HOOK ARM, 8MM; MEDIAL PORTAL, MARKING HOOK ARM, 9MM; T-FIX TUNL HK FOR MEDAL-PORT,11MM
Classification Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
Product Code: MDM
Device Class: 1
Regulation Number: 878.4800
Medical Specialty: General & Plastic Surgery
Registered Establishment Name: 3D MEDICAL MANUFACTURING, INC. (dba Tecomet)
Registered Establishment Number: 3001239363
Owner/Operator: 3D Medical Manufacturing, inc. DBA Tecomet
Owner/Operator Number: 10043250
Establishment Operations: Contract Manufacturer
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