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510(k) K944752

ORTHOMET RESURFACING FEMORAL COMPONENT by Orthomet, Inc. — Product Code KXA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 28, 1994
Date Received
September 26, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Femoral, Resurfacing
Device Class
Class II
Regulation Number
888.3400
Review Panel
OR
Submission Type

Other clearances by Orthomet, Inc.

  • K936310 — ORTHOMET HMC FEMORAL STEM COMPONENT (June 7, 1995)
  • K945783 — ORTHOMET TITANIUM HYBRID FEMORAL STEM (May 30, 1995)
  • K943873 — ORTHOMET ANATOMICALLY GUIDED CARPAL TUNNEL RELEASE SY (April 26, 1995)
  • K930771 — PERFECTA TOTAL HIP SYSTEM COATED COCR FEMORAL STEM (November 30, 1994)
  • K926334 — AXIOM TOTAL KNEE SYST/ACL RETAIN TIBIAL TRAY/INSER (October 18, 1994)
  • K931678 — ORTHOMET LHMC FEMORAL STEM (October 14, 1994)
  • K932677 — AXIOM TOTAL KNEE SYSTEM (October 14, 1994)
  • K931333 — ORTHOMET ACETABULAR CUP SYSTEM (October 14, 1994)
  • K925536 — HYBRID FEMORAL STEM, PERFECTA TOTAL HIP SYSTEM (January 7, 1994)
  • K923243 — PERFECTA TOTAL HIP SYSTEM (January 7, 1994)

Other clearances for product code KXA

  • K201219 — Biocore9 Femoral Head Resurfacing Component (January 19, 2021)
  • K092198 — CORMET CEMENTLESS RESURFACING FEMORAL HEAD (April 15, 2010)
  • K082673 — CONSERVE PRESSFIT FEMORAL COMPONENT (December 12, 2008)
  • K071053 — RECAP HA PRESS-FIT FEMORAL RESURFACING HEAD (June 29, 2007)
  • K070292 — DUROM HIP RESURFACING SYSTEM, FEMORAL COMPONENTS (April 26, 2007)
  • K062960 — CONSERVE FEMORAL RESURFACING COMPONENT (December 1, 2006)
  • K043542 — BIOPRO TARA FEMORAL RESURFACING COMPONENT (May 18, 2005)
  • K032659 — DEPUY ASR RESURFACING FEMORAL HEADS (December 4, 2003)
  • K023188 — PRESS-FIT HEAD RESURFACING DEVICE (December 11, 2002)
  • K021549 — CONTOURED ARTICULAR PROSTHESIS (CAP) FEMORAL HEAD RESURFACING SYSTEM (August 1, 2002)