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510(k) K802871

TIBIAL FRACTURE BRACE by Orthomedics — Product Code IQI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 1980
Date Received
November 14, 1980
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 Orthomedics

  • K832741 — JASON CERVICAL ORTHOSIS (September 20, 1983)
  • K832740 — FEMORAL FRACTURE ORTHOSIS (September 20, 1983)
  • K832742 — EXTENSION CONTROL KNEE ORTHOSIS (September 20, 1983)
  • K811456 — ORTHO-FRAC KIT (June 12, 1981)
  • K811297 — CERVICAL SUPPORT (May 27, 1981)
  • K811298 — EXECUTIVE COLLAR (May 27, 1981)
  • K810554 — LUMBAR FLEXION BRACE (March 13, 1981)
  • K810557 — HIP ABDUCTION SPLINT (March 13, 1981)
  • K810555 — SCOLIOSIS ORTHOTIC SYSTEM (March 13, 1981)
  • K810556 — SPINAL EXTENSION BRACE (March 13, 1981)

Other clearances for product code IQI

  • K143458 — Neurosplint (August 13, 2015)
  • K052771 — SENSOR WALK (May 3, 2006)
  • K031576 — SPARTAN ORTHOPAEDIC WRIST BRACE, MODEL SCT-1 (July 31, 2003)
  • K926391 — ACCUFLEX DYNAMIC ELBOW ORTHOSIS (July 22, 1993)
  • K910974 — MCCONNELL SHOULDER BRACE (March 21, 1991)
  • K874502 — GAIT-AID ORTHOPEDIC INSOLE (November 30, 1987)
  • K831542 — ADJUSTABLE POLYCENTRIC ELBOW HINGE (June 24, 1983)
  • K831615 — DROP FOOT BRACE (June 15, 1983)
  • K823812 — VARIOUS SUPPORTS AND SPLINTS (January 14, 1983)
  • K823113 — BRACE-UP ALL PURPOSE WRIST BAND (November 16, 1982)