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510(k) K953397

HEX-FIX FIELD FIXATOR by Smith & Nephew Richards, Inc. — Product Code LXT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1995
Date Received
July 20, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

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  • K962808 — ILIZAROV EXTERNAL FIXATION SYSTEM (August 19, 1996)
  • K962137 — GENESIS II CONSTRAINED SYSTEM (August 2, 1996)
  • K955767 — COFIED MODULAR SHOULDER SYSTEM (April 8, 1996)

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