510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K023564Substantially Equivalent

Osse-Lign

Osseus, LLC, Lawrenceville NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K023564 is the FDA 510(k) clearance record for OSSE-LIGN, a class II device, cleared for Osseus, LLC on under FDA product code JDQ (Cerclage, Fixation). FDA records list 2 510(k) clearances for Osseus, LLC, from to . As of , FDA records show no recalls naming K023564.

Clearance record

Decision date
Received
(139 days to decision)
Product code
JDQ Cerclage, Fixation
Regulation
21 CFR 888.3010
Device class
Class II
Review panel
Orthopedic
Applicant
Osseus, LLC 34 Woodlane Rd., Lawrenceville NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JDQ

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