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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K133256

ITOTAL CRUCIATE RETAINING, IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEMS, IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM · Conformis, Inc. · decided 2014-01-09 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
iDuo® Patella Implant Sizer1080-407Conformis, Inc.NPJ00850268007408
iDuo® Patella Trial 1080-403Conformis, Inc.NPJ00850268007378
iDuo® Patella Sizer1080-410Conformis, Inc.NPJ00850268007439
iDuo® Patella Sizer1080-409Conformis, Inc.NPJ00850268007422
iDuo® Patella Trial 1080-405Conformis, Inc.NPJ00850268007392
iDuo® Patella Trial 1080-404Conformis, Inc.NPJ00850268007385
iDuo® Patella Sizer1080-408Conformis, Inc.NPJ00850268007415
iDuo® Patella Trial 1080-402Conformis, Inc.NPJ00850268007361