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FDA 510(k) Applications Submitted by UNITED ORTHOPEDIC CORP.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K101670
06/14/2010
UNITED U2 BIPOLAR IMPLANT
UNITED ORTHOPEDIC CORP.
K140073
01/13/2014
U2 FEMORAL COMPONENT, CR, CEMENTED
UNITED ORTHOPEDIC CORP.
K140075
01/13/2014
U2 FEMORAL COMPONENT, CR, POROUS COATED
UNITED ORTHOPEDIC CORP.
K100981
04/09/2010
UNITED STEM, PSA TYPE
UNITED ORTHOPEDIC CORP.
K111546
06/03/2011
U2 HIP SYSTEM
UNITED ORTHOPEDIC CORP.
K121777
06/18/2012
U2 ACETABULAR CUP, PLASMA SPRAY
UNITED ORTHOPEDIC CORP.
K122183
07/23/2012
AUGMENT AND SCREW, PSA TYPE
UNITED ORTHOPEDIC CORP.
K122185
07/23/2012
U-MOTION II ACETABULAR SYSTEM
UNITED ORTHOPEDIC CORP.
K132455
08/06/2013
U-MOTION II PS+ CUP
UNITED ORTHOPEDIC CORP.
K103497
11/29/2010
CERAMIC FEMORAL HEAD
UNITED ORTHOPEDIC CORP.
K050262
02/04/2005
U2 ACETABULAR COMPONENT
UNITED ORTHOPEDIC CORP.
K050269
02/04/2005
U1 HIP SYSTEM - BIPOLAR
UNITED ORTHOPEDIC CORP.
K051640
06/20/2005
U2 TOTAL KNEE SYSTEM
UNITED ORTHOPEDIC CORP.
K062978
09/29/2006
U2 HIP STEM, TI PLASMA SPRAY
UNITED ORTHOPEDIC CORP.
K022520
07/30/2002
U2 ACETABULAR CUP
UNITED ORTHOPEDIC CORP.
K003237
10/17/2000
U2 HIP STEM, TI POROUS COATED
UNITED ORTHOPEDIC CORP.
K994078
12/02/1999
U1 HIP SYSTEM
UNITED ORTHOPEDIC CORP.
K021657
05/20/2002
UKNEE TOTAL KNEE SYSTEM
UNITED ORTHOPEDIC CORP.
K082424
08/22/2008
UNITED U2 TOTAL KNEE SYSTEM
UNITED ORTHOPEDIC CORP.
K082469
08/27/2008
UNITED U2 PATELLA
UNITED ORTHOPEDIC CORP.
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