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510(k) K823393

STAX FINGER SPLINTS by Orthopedic Systems, Inc. — Product Code ILH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 1982
Date Received
November 12, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Splint, Hand, And Components
Device Class
Class I
Regulation Number
890.3475
Review Panel
PM
Submission Type

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  • K890331 — FREEMAN TOTAL HIP SYSTEM RIDGED STEM (October 13, 1989)
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Other clearances for product code ILH

  • K832144 — SPLINT WOOD (August 1, 1983)
  • K831548 — SPLINTS (June 27, 1983)
  • K823647 — FINGER EXTENSION SPLINT (January 21, 1983)
  • K823644 — FINGER FLEXION SPLINT (January 21, 1983)
  • K823666 — UNIVERSAL WRIST SPLINT & FOREARM SPLINT (December 30, 1982)
  • K823601 — WRIST SUPPORT (December 22, 1982)
  • K823165 — WRIST SPLING & FOREARM SPLINT (November 16, 1982)
  • K822651 — TOTAL FINGER FLEXION SPLINT (September 17, 1982)
  • K821637 — WIRE-FOAM MP FLEXION SPRING (June 11, 1982)
  • K821635 — SOFT ULNAR DEVIATION SPLINTS (June 11, 1982)