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510(k) K934354

LACEY ALL POLYETHYLENE TIBIAL COMPONENT by Dow Corning Wright — Product Code JWH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 1994
Date Received
September 7, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device Class
Class II
Regulation Number
888.3560
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)
  • 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)
  • K926257 — ORTHOLOC ADVANTIM THICK TIBIAL BASE COMPONENT (May 18, 1993)

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