MedtechSourcebook

Plate, Cranioplasty, Preformed, Non-Alterable (GXN) contract manufacturers

11 US facilities list FDA product code GXN as a contract manufacturer (6) or contract sterilizer (5).

FDA-registered (openFDA, export of Oct 21, 2026)

FDA device name
Plate, Cranioplasty, Preformed, Non-Alterable
Product code
GXN (FDA product classification database)
Device class
Class II
Regulation
21 CFR 882.5330
Classification panel
Neurology
FDA flags
implant

Where they are

California 2 · Indiana 2 · Colorado 1 · Florida 1 · Massachusetts 1 · Maryland 1 · North Carolina 1 · Pennsylvania 1 · Texas 1

All 11 facilities

CompanyFDA registrationEstablishment typeDevice categoriesCity and stateCertificationUpdated
ANDERSEN SCIENTIFIC, INC.1064858Contract sterilizerGeneral and plastic surgery; Orthopedic; Cardiovascular +8 moreMorrisville, NCNot verifiedOct 21, 2026
BIOMET, INC.1825034Contract manufacturerOrthopedic; Dental; Neurology +3 moreWarsaw, INNot verifiedOct 21, 2026
CULVER TOOL & ENGINEERING3010047454Contract manufacturerOrthopedic; General and plastic surgery; Neurology +4 morePlymouth, INNot verifiedOct 21, 2026
Jabil Inc. (Brandywine)3015212339Contract manufacturerOrthopedic; General and plastic surgery; Dental +2 moreW Chester, PANot verifiedOct 21, 2026
Jabil Inc. (Monument)3015399803Contract manufacturerOrthopedic; General and plastic surgery; Neurology +3 moreMonument, CONot verifiedOct 21, 2026
KLS MARTIN MANUFACTURING, LLC3014483751Contract manufacturerDental; Orthopedic; Neurology +1 moreJacksonville, FLNot verifiedOct 21, 2026
LaunchPort LLC3015259858Contract sterilizerNeurology; Ear, nose and throat; Gastroenterology and urologyBaltimore, MDNot verifiedOct 21, 2026
Sterigenics U.S., LLC2029275Contract sterilizerGeneral and plastic surgery; Orthopedic; Cardiovascular +16 moreCorona, CANot verifiedOct 21, 2026
Sterigenics US LLC1649518Contract sterilizerOrthopedic; General and plastic surgery; General hospital +13 moreFort Worth, TXNot verifiedOct 21, 2026
Sterigenics US LLC2011171Contract sterilizerCardiovascular; General and plastic surgery; General hospital +13 moreLos Angeles, CANot verifiedOct 21, 2026
Viant AS&O Holdings, LLC1218882Contract manufacturerOrthopedic; Neurology; General and plastic surgery +3 moreBrimfield, MANot verifiedOct 21, 2026

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