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510(k) K910974

MCCONNELL SHOULDER BRACE by Mcconnell Orthopedic — Product Code IQI

K910974 is an FDA 510(k) premarket notification submitted by Mcconnell Orthopedic for the device "MCCONNELL SHOULDER BRACE". The FDA issued a decision of Substantially Equivalent on March 21, 1991. The device falls under product code IQI (Orthosis, Limb Brace), a Class I device regulated under 21 CFR 890.3475. Mcconnell Orthopedic has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 1991
Date Received
March 7, 1991
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 Mcconnell Orthopedic

  • K905565 — LATERAL BUTTRESS SUPPORT (February 21, 1991)
  • K905564 — PREP AND OPERATING STAND (February 21, 1991)
  • K885100 — MCCONNELL REAMER GUIDE (January 13, 1989)
  • K871839 — MCCONNELL ORTHOPEDIC PELVIC CALIPER SUPPORT (May 26, 1987)
  • K871840 — MCCONNELL ORTHOPEDIC ANKLE POSITIONER (May 26, 1987)
  • K871820 — MCCONNELL ORTHOPEDIC ANTERIOR TORSO-ARM SUPPORT (May 26, 1987)
  • K871822 — MCCONNELL ORTHOPEDIC U-HOOK ASSEMBLY (May 26, 1987)
  • K871824 — MCCONNELL ORTHOPEDIC SUSPENSION SYSTEM (May 26, 1987)
  • K871823 — MCCONNELL ORTHOPEDIC TIBIAL POSITIONER (May 26, 1987)
  • K871821 — MCCONNELL ORTHOPEDIC POSTERIOR BODY SUPPORT (May 26, 1987)

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)
  • 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)
  • K823160 — ROTATION BOOT (November 10, 1982)

FDA data resources