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510(k) K812423

NEOPRENE KNEE SUPPORT by Surgical Appliance Industries, Inc. — Product Code ITQ

K812423 is an FDA 510(k) premarket notification submitted by Surgical Appliance Industries, Inc. for the device "NEOPRENE KNEE SUPPORT". The FDA issued a decision of Substantially Equivalent on September 14, 1981. The device falls under product code ITQ (Joint, Knee, External 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
September 14, 1981
Date Received
August 24, 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)
  • K812401 — CRUCIFORM ANTERIOR SPINAL HYPEREXTEN. O (September 14, 1981)
  • K812422 — CUSTOM CONTOUR LUMBOSACRAL ORTHOSIS (September 14, 1981)
  • K811689 — CYLINDER KNEE CAST/SPLINT (June 25, 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)
  • 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)
  • K780892 — FRACTURE BRACING (June 13, 1978)

FDA data resources