510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K143100Substantially Equivalent

NP Cement HV Genta;NP Cement LV Genta;NP Cement HV System Genta;NP Cement LV System Genta

Cossington, Ltd., Kingston Upon Thames, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K143100 is the FDA 510(k) clearance record for NP Cement HV Genta;NP Cement LV Genta;NP Cement HV System Genta;NP Cement LV System Genta, a class II device, cleared for Cossington, Ltd. on under FDA product code LOD (Bone Cement). FDA records list 2 510(k) clearances for Cossington, Ltd. As of , FDA records show no recalls naming K143100.

Clearance record

Decision date
Received
(128 days to decision)
Product code
LOD Bone Cement
Regulation
21 CFR 888.3027
Device class
Class II
Review panel
Orthopedic
Applicant
Cossington, Ltd. 167-169 London Rd., Kingston Upon Thames, GB
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LOD

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