510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K102018Substantially Equivalent

Norian Reinforced, Norian Reinforced Fast Set Putty

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

K102018 is the FDA 510(k) clearance record for NORIAN REINFORCED, NORIAN REINFORCED FAST SET PUTTY, a class II device, cleared for Synthes USA Products, LLC 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 no recalls naming K102018.

Clearance record

Decision date
Received
(66 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 Products, LLC 1230 Wilson Dr., 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 November 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code GXP, trailing twelve months
MonthClearances
December 20250
January 20261
February 20260
March 20261
April 20260
May 20260
June 20261
July 20261
August 20260
September 20260
October 20260
November 20260