510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K913079Substantially Equivalent

02810-01/02810-02 Orthoranger Ii/02810-3 Rom 360

Lucas Sensing Systems, Inc., Phoenix AZ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K913079 is the FDA 510(k) clearance record for 02810-01/02810-02 ORTHORANGER II/02810-3 ROM 360, a class I device, cleared for Lucas Sensing Systems, Inc. on under FDA product code KQX (Goniometer, Ac-Powered). FDA records list one 510(k) clearance for Lucas Sensing Systems, Inc. As of , FDA records show no recalls naming K913079.

Clearance record

Decision date
Received
(76 days to decision)
Product code
KQX Goniometer, Ac-Powered
Regulation
21 CFR 888.1500
Device class
Class I
Review panel
Orthopedic
Applicant
Lucas Sensing Systems, Inc. 21640 N. 14th Ave., Phoenix AZ
510(k) summary
Statement
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