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BALANCED KNEE SYSTEM REVISION OFFSET TIBIA — Ortho Development (510(k) K103837)

BALANCED KNEE SYSTEM REVISION OFFSET TIBIA — Ortho Development (510(k) K103837) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: BALANCED KNEE SYSTEM REVISION OFFSET TIBIA; Applicant: Ortho Development; Clearance track: 510(k).

Device nameBALANCED KNEE SYSTEM REVISION OFFSET TIBIA
ApplicantOrtho Development
Clearance track510(k)
Submission numberK103837
DecisionSubstantially Equivalent
Decision date2011-03-24
Date received2010-12-30
Product codeJWH
Device class2
Medical specialtyOrthopedic
Applicant locationUT, US
SourceopenFDA device

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