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510(k) K780892

FRACTURE BRACING by Hosmer Dorrance Corp. — Product Code ITQ

K780892 is an FDA 510(k) premarket notification submitted by Hosmer Dorrance Corp. for the device "FRACTURE BRACING". The FDA issued a decision of Substantially Equivalent on June 13, 1978. The device falls under product code ITQ (Joint, Knee, External 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
June 13, 1978
Date Received
May 31, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Joint, Knee, External 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)
  • K801788 — HUMEROUS FRACTURE BRACE, ULNA FRACTURE (August 7, 1980)
  • K780891 — POST-OPERATIVE HIP ORTHOSIS (June 13, 1978)
  • K780890 — CAPP TERMINAL DEVICE (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 ITQ

  • K831044 — LIMITED MOTION FUNCTIONAL KNEE BRACE (June 24, 1983)
  • K831310 — BRACE C.T. (May 16, 1983)
  • K823658 — DELUXE KNEE IMMOBILIZER(UNIVERSAL) (December 30, 1982)
  • K823397 — ANATOMIC FRACTURE BRACE (November 29, 1982)
  • K823159 — DELUXE KNEE IMMOBILIZER (November 10, 1982)
  • K812423 — NEOPRENE KNEE SUPPORT (September 14, 1981)
  • K812094 — AIRCAST PNEUMATIC KNEE BRACE (August 13, 1981)
  • K811689 — CYLINDER KNEE CAST/SPLINT (June 25, 1981)
  • K810222 — LIMB ORHTOSIS (February 4, 1981)
  • K802673 — KNEE BRACE/STABILIZER (November 12, 1980)

FDA data resources