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510(k) K031576

SPARTAN ORTHOPAEDIC WRIST BRACE, MODEL SCT-1 by Surgitech, Inc. — Product Code IQI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 2003
Date Received
May 20, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthosis, Limb Brace
Device Class
Class I
Regulation Number
890.3475
Review Panel
PM
Submission Type

Other clearances by Surgitech, Inc.

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  • K910974 — MCCONNELL SHOULDER BRACE (March 21, 1991)
  • K874502 — GAIT-AID ORTHOPEDIC INSOLE (November 30, 1987)
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  • K823812 — VARIOUS SUPPORTS AND SPLINTS (January 14, 1983)
  • K823113 — BRACE-UP ALL PURPOSE WRIST BAND (November 16, 1982)
  • K823160 — ROTATION BOOT (November 10, 1982)