Medical Device Manufacturer · TW , Hsinchu

United Orthopedic Corp. - FDA 510(k) Cleared Devices

20 submissions · 20 cleared · Since 2000
20
Total
20
Cleared
0
Denied
FDA 510(k) Regulatory Record - United Orthopedic Corp. Orthopedic
20 devices
1-20 of 20
Cleared Jun 16, 2014
U2 FEMORAL COMPONENT, CR, CEMENTED
K140073 · JWH
Orthopedic · 154d
Cleared Jun 13, 2014
U2 FEMORAL COMPONENT, CR, POROUS COATED
K140075 · MBH
Orthopedic · 151d
Cleared Sep 03, 2013
U-MOTION II PS+ CUP
K132455 · LZO
Orthopedic · 28d
Cleared Feb 22, 2013
U-MOTION II ACETABULAR SYSTEM
K122185 · LZO
Orthopedic · 214d
Cleared Feb 05, 2013
AUGMENT AND SCREW, PSA TYPE
K122183 · JWH
Orthopedic · 197d
Cleared Jul 18, 2012
U2 ACETABULAR CUP, PLASMA SPRAY
K121777 · LPH
Orthopedic · 30d
Cleared Jul 01, 2011
U2 HIP SYSTEM
K111546 · LPH
Orthopedic · 28d
Cleared Mar 04, 2011
CERAMIC FEMORAL HEAD
K103497 · MEH
Orthopedic · 95d
Cleared Oct 08, 2010
UNITED U2 BIPOLAR IMPLANT
K101670 · KWY
Orthopedic · 116d
Cleared Jun 14, 2010
UNITED STEM, PSA TYPE
K100981 · JWH
Orthopedic · 66d
Cleared Dec 16, 2008
UNITED U2 TOTAL KNEE SYSTEM
K082424 · JWH
Orthopedic · 116d
Cleared Sep 26, 2008
UNITED U2 PATELLA
K082469 · JWH
Orthopedic · 30d
Cleared Jan 16, 2007
U2 HIP STEM, TI PLASMA SPRAY
K062978 · LWJ
Orthopedic · 109d
Cleared Mar 01, 2006
U2 TOTAL KNEE SYSTEM
K051640 · JWH
Orthopedic · 254d
Cleared Aug 29, 2005
U1 HIP SYSTEM - BIPOLAR
K050269 · KWY
Orthopedic · 206d
Cleared Aug 15, 2005
U2 ACETABULAR COMPONENT
K050262 · LWJ
Orthopedic · 192d
Cleared Feb 25, 2003
U2 ACETABULAR CUP
K022520 · LPH
Orthopedic · 210d
Cleared Aug 12, 2002
UKNEE TOTAL KNEE SYSTEM
K021657 · JWH
Orthopedic · 84d
Cleared Jan 10, 2001
U2 HIP STEM, TI POROUS COATED
K003237 · LPH
Orthopedic · 85d
Cleared Dec 04, 2000
U1 HIP SYSTEM
K994078 · LPH
Orthopedic · 368d
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