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510(k) K140075

U2 FEMORAL COMPONENT, CR, POROUS COATED by United Orthopedic Corp. — Product Code MBH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 2014
Date Received
January 13, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Device Class
Class II
Regulation Number
888.3565
Review Panel
OR
Submission Type

Other clearances by United Orthopedic Corp.

  • K140073 — U2 FEMORAL COMPONENT, CR, CEMENTED (June 16, 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)
  • K082424 — UNITED U2 TOTAL KNEE SYSTEM (December 16, 2008)

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