MedtechSourcebook

Methyl Methacrylate For Cranioplasty (GXP) contract manufacturers

8 US facilities list FDA product code GXP as a contract manufacturer (3) or contract sterilizer (5).

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

FDA device name
Methyl Methacrylate For Cranioplasty
Product code
GXP (FDA product classification database)
Device class
Class II
Regulation
21 CFR 882.5300
Classification panel
Neurology
FDA flags
implant

Where they are

California 4 · Florida 1 · Mississippi 1 · New Jersey 1 · New York 1

All 8 facilities

CompanyFDA registrationEstablishment typeDevice categoriesCity and stateCertificationUpdated
ISOMEDIX OPERATIONS INC.2245304Contract sterilizerOrthopedic; General and plastic surgery; Dental +9 moreWhippany, NJNot verifiedOct 21, 2026
KLS MARTIN MANUFACTURING, LLC3014483751Contract manufacturerDental; Orthopedic; Neurology +1 moreJacksonville, FLNot verifiedOct 21, 2026
Olive Branch Distribution Center3016050940Contract manufacturerOrthopedic; General and plastic surgery; Neurology +4 moreOlive Branch, MSNot verifiedOct 21, 2026
PDV MedTech3008514120Contract manufacturerCardiovascular; Orthopedic; General hospital +2 moreMorgan Hill, CANot verifiedOct 21, 2026
Sterigenics U.S. LLC2953359Contract sterilizerGeneral and plastic surgery; Orthopedic; Ophthalmic +11 moreHayward, CANot verifiedOct 21, 2026
Sterigenics U.S., LLC1319639Contract sterilizerCardiovascular; General and plastic surgery; Gastroenterology and urology +14 moreQueensbury, NYNot verifiedOct 21, 2026
Sterigenics U.S., LLC2029275Contract sterilizerGeneral and plastic surgery; Orthopedic; Cardiovascular +16 moreCorona, CANot verifiedOct 21, 2026
Sterigenics US LLC2011171Contract sterilizerCardiovascular; General and plastic surgery; General hospital +13 moreLos Angeles, CANot verifiedOct 21, 2026

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