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510(k) K051640

U2 TOTAL KNEE SYSTEM by United Orthopedic Corp. — Product Code JWH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 2006
Date Received
June 20, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device Class
Class II
Regulation Number
888.3560
Review Panel
OR
Submission Type

Other clearances by United Orthopedic Corp.

  • K140073 — U2 FEMORAL COMPONENT, CR, CEMENTED (June 16, 2014)
  • K140075 — U2 FEMORAL COMPONENT, CR, POROUS COATED (June 13, 2014)
  • K132455 — U-MOTION II PS+ CUP (September 3, 2013)
  • K122185 — U-MOTION II ACETABULAR SYSTEM (February 22, 2013)
  • K122183 — AUGMENT AND SCREW, PSA TYPE (February 5, 2013)
  • K121777 — U2 ACETABULAR CUP, PLASMA SPRAY (July 18, 2012)
  • K111546 — U2 HIP SYSTEM (July 1, 2011)
  • K103497 — CERAMIC FEMORAL HEAD (March 4, 2011)
  • K101670 — UNITED U2 BIPOLAR IMPLANT (October 8, 2010)
  • K100981 — UNITED STEM, PSA TYPE (June 14, 2010)

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