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510(k) K920593

CERAMIC FEMORAL HEAD by Dow Corning Wright — Product Code LZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 31, 1992
Date Received
February 11, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Device Class
Class II
Regulation Number
888.3353
Review Panel
OR
Submission Type

Other clearances by Dow Corning Wright

  • K932210 — ORTHOLOC ADVANTIM REVISION FEMORAL COMPONENT (September 7, 1994)
  • K932911 — ORTHOLOC ADVANTIM L.S. TIBIAL COMPONENT (June 30, 1994)
  • K934354 — LACEY ALL POLYETHYLENE TIBIAL COMPONENT (June 3, 1994)
  • K932222 — SLT FEMORAL HEAD (May 27, 1994)
  • K932858 — ORTHOLOC ADVANTIM TIBIAL BASE COMPONENT (February 16, 1994)
  • K930228 — ORTHOLOC ADVANTIM TIBIAL STEM 5 DEGREE (November 30, 1993)
  • K925900 — LACEY REVISION FEMORAL COMPONENT (August 24, 1993)
  • K930189 — ORTHOLOC(R) ADVANTIM(TM) POSTERIOR STAB FEMOR COMP (August 6, 1993)
  • K930188 — ORTHOLOC(R) ADVANTIM(TM) FEMORAL COMPONENT (August 3, 1993)
  • K930190 — ORTHOLOC(R) ADVANTIM(TM) NON-POR COAT FEMOR COMP (August 2, 1993)

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