FDA 510(k) Applications Submitted by United Orthopedic Corporation

FDA 510(k) Number Submission Date Device Name Applicant
K130149 01/22/2013 U2 HIP SYSTEM, EXPANDED INDICATIONS FOR USE UNITED ORTHOPEDIC CORPORATION
K110245 01/27/2011 UNITED UTF STEM UNITED ORTHOPEDIC CORPORATION
K120507 02/21/2012 UNITED U2 FEMORAL COMPONENT, PS, #7 UNITED ORTHOPEDIC CORPORATION
K150829 03/30/2015 U2 Total Knee System- Additional Sizes UNITED ORTHOPEDIC CORPORATION
K150832 03/30/2015 U2 Femoral Component, CR, Porous Coated, Additional Sizes UNITED ORTHOPEDIC CORPORATION
K131116 04/22/2013 U2 TOTAL KNEE SYSTEM - PSA TYPE, OFFSET STEM ADAPTER UNITED ORTHOPEDIC CORPORATION
K131864 06/24/2013 U2 TIBIAL BASEPLATE- CMA TYPE, TIBIAL INSERT AND AUGMENT UNITED ORTHOPEDIC CORPORATION
K132207 07/16/2013 UTF STEM-REDUCED, ADDITIONAL SIZES UNITED ORTHOPEDIC CORPORATION
K122504 08/16/2012 FEMORAL HEADS, 2.5 AND 7.5 MM NECK LENGTH UNITED ORTHOPEDIC CORPORATION
K112463 08/26/2011 UNITED 36MM CERAMIC FEMORAL HEAD, DELTA UNITED ORTHOPEDIC CORPORATION
K132752 09/03/2013 ULTRACONGRUENT INSERT UNITED ORTHOPEDIC CORPORATION
K123550 11/19/2012 UTF STEM, REDUCED UNITED ORTHOPEDIC CORPORATION
K103733 12/22/2010 UNITED U2 XPE TOTAL KNEE SYSTEM UNITED ORTHOPEDIC CORPORATION
K170089 01/10/2017 U-Motion II Acetabular Systemù Additional sizes United Orthopedic Corporation
K172251 07/26/2017 UTS Stem United Orthopedic Corporation
K172833 09/19/2017 E-XPE Acetabular Components and U-Motion II Acetabular Cup United Orthopedic Corporation
K162957 10/24/2016 U2 Femoral Head UNITED ORTHOPEDIC CORPORATION
K163193 11/15/2016 UTF Stem, reduced, #0, #00 UNITED ORTHOPEDIC CORPORATION
K163441 12/08/2016 Locking Cage, Full XPE Cup UNITED ORTHOPEDIC CORPORATION
K161360 05/16/2016 U2 Total Knee System, PSA Tibial Insert UNITED ORTHOPEDIC CORPORATION
K151316 05/18/2015 U2 Hip Stem, Ti Porous Coated, Matrix United Orthopedic Corporation
K161705 06/20/2016 U2 Total Knee System E-XPE products UNITED ORTHOPEDIC CORPORATION
K152430 08/26/2015 All Poly Tibial Component UNITED ORTHOPEDIC CORPORATION
K152439 08/27/2015 U2 Bipolar Implant and 22mm Femoral Head UNITED ORTHOPEDIC CORPORATION
K152530 09/03/2015 UCP Stem UNITED ORTHOPEDIC CORPORATION
K190100 01/22/2019 USTAR II System United Orthopedic Corporation
K210961 03/31/2021 U2 Total Knee System, XPE Tibial Insert, PS PLUS United Orthopedic Corporation
K191056 04/19/2019 Conformity stem, cemented United Orthopedic Corporation
K221149 04/20/2022 U-Motion II Acetabular System-Extension line United Orthopedic Corporation
K221675 06/09/2022 United U2 femoral head, 22mm delta ceramic head United Orthopedic Corporation
K221705 06/13/2022 U2 Total Knee System-PF+ United Orthopedic Corporation
K222700 09/07/2022 Tibial baseplate, Tibial insert United Orthopedic Corporation
K183312 11/29/2018 Conformity Stem United Orthopedic Corporation


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