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510(k) K811690

ANKLE-FOOT CAST/SPLINT by Surgical Appliance Industries, Inc. — Product Code IQI

K811690 is an FDA 510(k) premarket notification submitted by Surgical Appliance Industries, Inc. for the device "ANKLE-FOOT CAST/SPLINT". The FDA issued a decision of Substantially Equivalent on June 25, 1981. The device falls under product code IQI (Orthosis, Limb Brace), a Class I device regulated under 21 CFR 890.3475. Surgical Appliance Industries, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 1981
Date Received
June 15, 1981
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 Surgical Appliance Industries, Inc.

  • K121106 — TRUFORM READY-TO-WEAR COMPRESSION ARM SLEECE TRUFORM READY-TO-WEAR COMPRESSION G (April 27, 2012)
  • K821682 — TRUNCAL ORTHOSIS (June 24, 1982)
  • K813416 — EXTERNAL BREAST PROSTHESIS (January 18, 1982)
  • K812423 — NEOPRENE KNEE SUPPORT (September 14, 1981)
  • K812422 — CUSTOM CONTOUR LUMBOSACRAL ORTHOSIS (September 14, 1981)
  • K812401 — CRUCIFORM ANTERIOR SPINAL HYPEREXTEN. O (September 14, 1981)
  • K811689 — CYLINDER KNEE CAST/SPLINT (June 25, 1981)
  • K811494 — LUMBO-SACRAL FLEXION ORTHOSIS (June 16, 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)

FDA data resources