CYLINDER KNEE CAST/SPLINT— 510(k) K811689

Name: FDA 510(k) clearance K811689
Creator: U.S. Food and Drug Administration
Published: 1981-06-25

Substantially Equivalent

Surgical Appliance Industries, Inc.

FDA 510(k) clearance K811689 for CYLINDER KNEE CAST/SPLINT, Substantially Equivalent on 1981-06-25. Applicant: Surgical Appliance Industries, Inc.. Device class: 1.

Clearance details

Applicant: Surgical Appliance Industries, Inc.
Product code: Code ITQ
Device class: Class 1
Regulation: 21 CFR 890.3475
Advisory panel: Physical Medicine
Date received: 1981-06-15
Decision date: 1981-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code ITQ

view all

K831044 — LIMITED MOTION FUNCTIONAL KNEE BRACE1983-06-24
K831310 — BRACE C.T.1983-05-16
K823658 — DELUXE KNEE IMMOBILIZER(UNIVERSAL)1982-12-30
K823397 — ANATOMIC FRACTURE BRACE1982-11-29
K823159 — DELUXE KNEE IMMOBILIZER1982-11-10

More clearances from Surgical Appliance Industries, Inc.

view all

K121106 — TRUFORM READY-TO-WEAR COMPRESSION ARM SLEECE TRUFORM READY-TO-WEAR COMPRESSION GAUNTLET2012-04-27
K821682 — TRUNCAL ORTHOSIS1982-06-24
K813416 — EXTERNAL BREAST PROSTHESIS1982-01-18
K812401 — CRUCIFORM ANTERIOR SPINAL HYPEREXTEN. O1981-09-14
K812422 — CUSTOM CONTOUR LUMBOSACRAL ORTHOSIS1981-09-14

Data sourced from openFDA. This site is unofficial and independent of the FDA.