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510(k) K994153

CORMET 2000 HEMI HIP METALLIC RESURFACING PROSTHESIS by Corin USA — Product Code KXA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 25, 2000
Date Received
December 8, 1999
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 Corin USA

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  • K193545 — Corin Optimized Positioning System (OPS) Femoral (August 4, 2020)
  • K193042 — Optimized Positioning System (OPS) ReView (June 26, 2020)
  • K192656 — Optimized Positioning System (OPS) Insight (May 1, 2020)
  • K190143 — LARS AC Band Device (November 4, 2019)
  • K190834 — Corin Optimized Position System Functional Hip Analysis (OPS FHA) (July 22, 2019)
  • K183038 — Corin Optimized Positioning System (OPS) Plan (November 26, 2018)
  • K181061 — Corin Optimized Positioning System (OPS) Femoral (September 7, 2018)
  • K152893 — Corin Optimized Positioning System (OPS) (June 3, 2016)

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)