510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K811689Substantially Equivalent

Cylinder Knee Cast/splint

Surgical Appliance Industries, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K811689 is the FDA 510(k) clearance record for CYLINDER KNEE CAST/SPLINT, a class I device, cleared for Surgical Appliance Industries, Inc. on under FDA product code ITQ (Joint, Knee, External Brace). FDA records list 9 510(k) clearances for Surgical Appliance Industries, Inc., from to . As of , FDA records show no recalls naming K811689.

Clearance record

Decision date
Received
(10 days to decision)
Product code
ITQ Joint, Knee, External Brace
Regulation
21 CFR 890.3475
Device class
Class I
Review panel
Physical Medicine
Applicant
Surgical Appliance Industries, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code ITQ

Trailing 12 months

FDA records hold no clearances under product code ITQ in the trailing twelve months.

FDA records show no clearances under product code ITQ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code ITQ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260