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OPTETRAK TOTAL KNEE SYSTEM, HI-FLEX ASYMMETRIC POSTERIOR-STABILIZED CEMENTED FEMORAL COMPO — Exactech, Inc. (510(k) K033883)

OPTETRAK TOTAL KNEE SYSTEM, HI-FLEX ASYMMETRIC POSTERIOR-STABILIZED CEMENTED FEMORAL COMPO — Exactech, Inc. (510(k) K033883) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: OPTETRAK TOTAL KNEE SYSTEM, HI-FLEX ASYMMETRIC POSTERIOR-STABILIZED CEMENTED FEMORAL COMPO; Applicant: Exa

Device nameOPTETRAK TOTAL KNEE SYSTEM, HI-FLEX ASYMMETRIC POSTERIOR-STABILIZED CEMENTED FEMORAL COMPO
ApplicantExactech, Inc.
Clearance track510(k)
Submission numberK033883
DecisionSubstantially Equivalent
Decision date2004-02-13
Date received2003-12-15
Product codeJWH
Device class2
Medical specialtyOrthopedic
Applicant locationFL, US
SourceopenFDA device

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