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510(k) K962541

REFLECTION ACETABULAR REINFORCEMENT RINGS by Smith & Nephew Richards, Inc. — Product Code JDJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 1996
Date Received
June 28, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical, Acetabular, Hip, Prosthesis
Device Class
Class II
Regulation Number
878.3300
Review Panel
OR
Submission Type

Other clearances by Smith & Nephew Richards, Inc.

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  • K963509 — GLOBAL TAPER TAPERED HIP SYSTEM, GT SPECTRON (January 27, 1997)
  • K960444 — FINN ROD TO ROD CONNECTOR (January 24, 1997)
  • K964163 — TRIMAX NAIL SYSTEM (December 27, 1996)
  • K962557 — GENESIS II ZIRCONIUM FEMORAL COMPONENT/PROFIX ZIRCONIUM FEMORAL COMPONENT (December 5, 1996)
  • K963486 — REVISION HIP SYSTEM (November 27, 1996)
  • K962808 — ILIZAROV EXTERNAL FIXATION SYSTEM (August 19, 1996)
  • K962137 — GENESIS II CONSTRAINED SYSTEM (August 2, 1996)
  • K955767 — COFIED MODULAR SHOULDER SYSTEM (April 8, 1996)
  • K960094 — REFLECTION DUAL DIMENSION SHELL (March 27, 1996)

Other clearances for product code JDJ

  • K972760 — LINK, ACETABULAR REVISION MESH CUP (October 22, 1997)
  • K970957 — OSTEONICS RESTORATION ACETABULAR RING (June 3, 1997)
  • K963940 — EXETER MESH (February 13, 1997)
  • K962007 — PROTRUSION CAGES (August 1, 1996)
  • K925883 — OSTEONICS MICROSTRUCTURED ACETABULAR COMPONENTS (June 15, 1993)
  • K890450 — INTERMEDICS APR(TM) II FEMORAL COMPONENT (August 9, 1989)