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
K200587Substantially Equivalent

VERASENSE for Exactech Equinoxe Size 38 mm, VERASENSE for Exactech Equinoxe Size 42 mm, LinkStation MINI, LinkStation MINI Evaluation Kit, VERASENSE Software Application for Shoulder

Orthosensor, Inc., Dania Beach FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K200587 is the FDA 510(k) clearance record for VERASENSE for Exactech Equinoxe Size 38 mm, VERASENSE for Exactech Equinoxe Size 42 mm, LinkStation MINI, LinkStation MINI Evaluation Kit, VERASENSE Software Application for Shoulder, a class II device, cleared for Orthosensor, Inc. on under FDA product code ONN (Intraoperative Orthopedic Joint Assessment Aid). FDA's definition for product code ONN reads: "Measurement and interpretation of orthopedic joint information". FDA records list 8 510(k) clearances for Orthosensor, Inc., from to . As of , FDA records show no recalls naming K200587.

Clearance record

Decision date
Received
(172 days to decision)
Product code
ONN Intraoperative Orthopedic Joint Assessment Aid
Regulation
21 CFR 882.4560
Device class
Class II
Review panel
Neurology
Applicant
Orthosensor, Inc. 1855 Griffin Rd. Suite A-310, Dania Beach FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code ONN

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