510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K011827Substantially Equivalent

Ortelius 800

Orthoscan, Inc., Ra'Ananna, IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K011827 is the FDA 510(k) clearance record for ORTELIUS 800, a class I device, cleared for Orthoscan , Ltd. on under FDA product code KQX (Goniometer, Ac-Powered). FDA records list 6 510(k) clearances for Orthoscan , Ltd., from to . As of , FDA records show no recalls naming K011827.

Clearance record

Decision date
Received
(77 days to decision)
Product code
KQX Goniometer, Ac-Powered
Regulation
21 CFR 888.1500
Device class
Class I
Review panel
Orthopedic
Applicant
Orthoscan , Ltd. 17 Ahuzah St., Ra'Ananna, IL
510(k) summary
Summary
Third party review
No

Clearances, product code KQX

Trailing 12 months

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

FDA records show no clearances under product code KQX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KQX, 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