510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K060445Substantially Equivalent

Norian Crs Bone Cement

Synthes (USA) Products LLC, West Chester PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K060445 is the FDA 510(k) clearance record for NORIAN CRS BONE CEMENT, a class II device, cleared for Synthes (Usa) on under FDA product code GXP (Methyl Methacrylate For Cranioplasty). FDA records list 479 510(k) clearances for Synthes (USA) Products LLC, from to . As of , FDA records show one recall naming K060445.

Clearance record

Decision date
Received
(51 days to decision)
Product code
GXP Methyl Methacrylate For Cranioplasty
Regulation
21 CFR 882.5300
Device class
Class II
Review panel
Neurology
Applicant
Synthes (Usa) 1302 Wrights Ln. E., West Chester PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GXP

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