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510(k) K811689

CYLINDER KNEE CAST/SPLINT by Surgical Appliance Industries, Inc. — Product Code ITQ

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
Joint, Knee, External 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)
  • K812401 — CRUCIFORM ANTERIOR SPINAL HYPEREXTEN. O (September 14, 1981)
  • K812422 — CUSTOM CONTOUR LUMBOSACRAL ORTHOSIS (September 14, 1981)
  • K811690 — ANKLE-FOOT CAST/SPLINT (June 25, 1981)
  • K811494 — LUMBO-SACRAL FLEXION ORTHOSIS (June 16, 1981)

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)
  • K810222 — LIMB ORHTOSIS (February 4, 1981)
  • K802673 — KNEE BRACE/STABILIZER (November 12, 1980)
  • K780892 — FRACTURE BRACING (June 13, 1978)