510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K130380Substantially Equivalent

Orthosensor Knee Balancer

Orthosensor, Inc., Sunrise FL / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K130380 is the FDA 510(k) clearance record for ORTHOSENSOR KNEE BALANCER, 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 one recall naming K130380.

Clearance record

Decision date
Received
(119 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. 1560 Sawgrass Corporate Pkwy., Sunrise 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