Tgm Medical, Inc. - FDA 510(k) Cleared Devices
Recent clearances: TGM Biolox delta Ceramic Heads, MILESTONE REVISION KNEE SYSTEM (MRKS) - FEMORAL COMPONENT, TIBIAL BASEPLATE, TIBIAL INSERT, STEMS, FEMORAL & TIBIAL AUGM, TREASURE BIPOLAR HEAD, FEMORAL HEAD, TREASURE BIPOLAR HEAD, INSERT
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Tgm Medical, Inc. Orthopedic ✕
5 devices
Cleared
Sep 09, 2015
TGM Biolox delta Ceramic Heads
Orthopedic
187d
Cleared
May 03, 2013
MILESTONE REVISION KNEE SYSTEM (MRKS) - FEMORAL COMPONENT, TIBIAL BASEPLATE,...
Orthopedic
109d
Cleared
Nov 05, 2012
TREASURE BIPOLAR HEAD, FEMORAL HEAD, TREASURE BIPOLAR HEAD, INSERT
Orthopedic
168d
Cleared
Oct 24, 2012
ZENITH, FEMORAL STEM ZENITH, DISTAL CENTRALIZER FOMORAL HEAD ACETABULAR INSERT
Orthopedic
142d
Cleared
Nov 04, 2011
MILESTONE KNEE SYSTEM, FEMORAL COMPONENT, POSTERIOR STABLIZED, UNOCATED /...
Orthopedic
87d