510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K140550Substantially Equivalent

Orthohub External Fixator Software

Orthohub, Inc., Menlo Park CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K140550 is the FDA 510(k) clearance record for ORTHOHUB EXTERNAL FIXATOR SOFTWARE, a class II device, cleared for Orthohub, Inc. 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 one 510(k) clearance for Orthohub, Inc. As of , FDA records show no recalls naming K140550.

Clearance record

Decision date
Received
(174 days to decision)
Product code
OSN Software For Diagnosis/Treatment
Regulation
21 CFR 888.3030
Device class
Class II
Review panel
Orthopedic
Applicant
Orthohub, Inc. 999 Menlo Oaks Dr., Menlo Park CA
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