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510(k) K050269

U1 HIP SYSTEM - BIPOLAR by United Orthopedic Corp. — Product Code KWY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 2005
Date Received
February 4, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Device Class
Class II
Regulation Number
888.3390
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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  • K191016 — COPAL exchange G Hip and Knee Spacers (November 1, 2019)
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  • K191569 — Implantcast ic-Bipolar Head System (August 28, 2019)