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510(k) K021549

CONTOURED ARTICULAR PROSTHESIS (CAP) FEMORAL HEAD RESURFACING SYSTEM by Std Mfg., Inc. — Product Code KXA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 1, 2002
Date Received
May 13, 2002
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 Std Mfg., Inc.

  • K023096 — CONTOURED ARTICULAR PROSTHESIS (CAP) HUMERAL HEAD RESURFACING SYSTEM (April 10, 2003)
  • K012362 — MODIFICATION TO VASCULAR CLOSURE DEVICE (August 23, 2001)
  • K003169 — VASCULAR CLOSURE DEVICE (December 8, 2000)
  • K000608 — SUCTION VASCULAR STAPLER AND IMPLANTABLE STAPLE SYSTEM (March 7, 2000)
  • K930427 — STD IRRIGATION PUMP (June 1, 1993)

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)
  • K021799 — CEMENTED FEMORAL HEAD RESURFING DEVICE (June 26, 2002)