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510(k) K101670

UNITED U2 BIPOLAR IMPLANT by United Orthopedic Corp. — Product Code KWY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 8, 2010
Date Received
June 14, 2010
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)
  • K100981 — UNITED STEM, PSA TYPE (June 14, 2010)
  • K082424 — UNITED U2 TOTAL KNEE SYSTEM (December 16, 2008)

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  • K221794 — Vario-Cup System (July 20, 2022)
  • K220492 — COPAL exchange G hip spacer (March 23, 2022)
  • K200709 — Kyocera Bipolar Hip System (April 17, 2020)
  • K192236 — Fitmore Hip Stem (November 5, 2019)
  • K191016 — COPAL exchange G Hip and Knee Spacers (November 1, 2019)
  • K191297 — iNSitu Bipolar Hip System (September 17, 2019)
  • K191569 — Implantcast ic-Bipolar Head System (August 28, 2019)