510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K180539Substantially Equivalent

Deformity Analysis and Correction Software (DACS) and Instrumentation

Arrowhead Medical Device Technologies, LLC, Collierville TN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K180539 is the FDA 510(k) clearance record for Deformity Analysis and Correction Software (DACS) and Instrumentation, a class II device, cleared for Arrowhead Medical Device Technologies, LLC 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 2 510(k) clearances for Arrowhead Medical Device Technologies, LLC, from to . As of , FDA records show no recalls naming K180539.

Clearance record

Decision date
Received
(166 days to decision)
Product code
OSN Software For Diagnosis/Treatment
Regulation
21 CFR 888.3030
Device class
Class II
Review panel
Orthopedic
Applicant
Arrowhead Medical Device Technologies, LLC 328 Poplar View Ln. E., Suite 2, Collierville TN
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