510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K253764Substantially Equivalent

ENOS Software Guided External Fixation System

Disior Oy, Helsinki Uusimaa FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K253764 is the FDA 510(k) clearance record for ENOS Software Guided External Fixation System, a class II device, cleared for Disior, Ltd. on under FDA product code OSN (Software For Diagnosis/Treatment). FDA's definition for product code OSN reads: "Software associated with an orthopedic trauma device which is intended for the diagnosis or treatment of traumatic or reconstructive orthopedic conditions". FDA records list 6 510(k) clearances for Disior, Ltd., from to . As of , FDA records show no recalls naming K253764.

Clearance record

Decision date
Received
(93 days to decision)
Product code
OSN Software For Diagnosis/Treatment
Regulation
21 CFR 888.3030
Device class
Class II
Review panel
Orthopedic
Applicant
Disior, Ltd. Htc Helsinki, Bldg. Pinta, Tammasaarenkatu 3, Helsinki Uusimaa FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OSN

Trailing 12 months
1 clearance under product code OSN in the twelve months to October 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code OSN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260