510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K944092Substantially Equivalent

Additional Accessories for the Orthofix System

Orthofix SRL, Rockville MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K944092 is the FDA 510(k) clearance record for ADDITIONAL ACCESSORIES FOR THE ORTHOFIX SYSTEM, a class II device, cleared for Orthofix Srl on under FDA product code JEC (Component, Traction, Invasive). FDA records list 102 510(k) clearances for Orthofix Srl, from to . As of , FDA records show no recalls naming K944092.

Clearance record

Decision date
Received
(225 days to decision)
Product code
JEC Component, Traction, Invasive
Regulation
21 CFR 888.3040
Device class
Class II
Review panel
Orthopedic
Applicant
Orthofix Srl 12300 Twinbrook Pkwy., Suite 625, Rockville MD
510(k) summary
Summary
Third party review
No

Clearances, product code JEC

Trailing 12 months

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

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