510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K941048Substantially Equivalent

True/lok Monolateral/bilateral Fixator

Applied Osteo Systems, Inc., Walnut Creek CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K941048 is the FDA 510(k) clearance record for TRUE/LOK MONOLATERAL/BILATERAL FIXATOR, a class II device, cleared for Applied Osteo Systems, Inc. on under FDA product code LXT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite). FDA records list 15 510(k) clearances for Applied Osteo Systems, Inc., from to . As of , FDA records show one recall naming K941048.

Clearance record

Decision date
Received
(210 days to decision)
Product code
LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
Regulation
21 CFR 888.3030
Device class
Class II
Review panel
Orthopedic
Applicant
Applied Osteo Systems, Inc. 1243 Alpine Rd., Walnut Creek CA
510(k) summary
Summary
Third party review
No

Clearances, product code LXT

Trailing 12 months

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

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