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

Clearance record K123721

GMK REVISION EXTENSION · Medacta International · decided 2013-07-26 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
GMK Revision Total Knee System02.07.0684RMedacta International SAJWH07630030819391
GMK Revision Total Knee System02.07.0685LMedacta International SAJWH07630030819407
GMK Revision Total Knee System02.07.0681RMedacta International SAJWH07630030819339
GMK Revision Total Knee System02.07.0683LMedacta International SAJWH07630030819360
GMK Revision Total Knee System02.07.0685RMedacta International SAJWH07630030819414
GMK Revision Total Knee System02.07.0682RMedacta International SAJWH07630030819353
GMK Revision Total Knee System02.07.0682LMedacta International SAJWH07630030819346
GMK Revision Total Knee System02.07.0686LMedacta International SAJWH07630030819421
GMK Revision Total Knee System02.07.0681LMedacta International SAJWH07630030819322
GMK Revision Total Knee System02.07.0683RMedacta International SAJWH07630030819377
GMK Revision Total Knee System02.07.0684LMedacta International SAJWH07630030819384
GMK Revision Total Knee System02.07.0686RMedacta International SAJWH07630030819438