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510(k) K801788

HUMEROUS FRACTURE BRACE, ULNA FRACTURE by Hosmer Dorrance Corp. — Product Code IQI

K801788 is an FDA 510(k) premarket notification submitted by Hosmer Dorrance Corp. for the device "HUMEROUS FRACTURE BRACE, ULNA FRACTURE". The FDA issued a decision of Substantially Equivalent on August 7, 1980. The device falls under product code IQI (Orthosis, Limb Brace), a Class I device regulated under 21 CFR 890.3475. Hosmer Dorrance Corp. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 1980
Date Received
July 29, 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 Hosmer Dorrance Corp.

  • K822632 — ELBOW PROSTHESIS (September 14, 1982)
  • K821704 — FRACTURE BRACING (June 24, 1982)
  • K780891 — POST-OPERATIVE HIP ORTHOSIS (June 13, 1978)
  • K780890 — CAPP TERMINAL DEVICE (June 13, 1978)
  • K780892 — FRACTURE BRACING (June 13, 1978)
  • K761312 — ORTHOTIC BRACING (January 10, 1977)
  • K761314 — FLEXION-BRAKING KNEE-SHIN ASSEMBLY (January 10, 1977)
  • K761313 — 4-BAR KNEE-SHIN SET-UP (January 10, 1977)

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