MedtechSourcebook

Cover, Burr Hole (GXR) contract manufacturers

14 US facilities list FDA product code GXR as a contract manufacturer (7) or contract sterilizer (7).

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

FDA device name
Cover, Burr Hole
Product code
GXR (FDA product classification database)
Device class
Class II
Regulation
21 CFR 882.5250
Classification panel
Neurology
FDA flags
implant

Where they are

California 3 · Massachusetts 2 · Minnesota 2 · Colorado 1 · Florida 1 · Indiana 1 · Missouri 1 · New York 1 · Texas 1 · Utah 1

All 14 facilities

CompanyFDA registrationEstablishment typeDevice categoriesCity and stateCertificationUpdated
BIOMET, INC.1825034Contract manufacturerOrthopedic; Dental; Neurology +3 moreWarsaw, INNot verifiedOct 21, 2026
Isomedix Operations, Inc.2183744Contract sterilizerCardiovascular; General and plastic surgery; Gastroenterology and urology +13 moreMinneapolis, MNNot verifiedOct 21, 2026
Jabil Inc. (Elmira)3015440604Contract manufacturerOrthopedic; Dental; General and plastic surgery +2 moreHorseheads, NYNot verifiedOct 21, 2026
Jabil Inc. (Monument)3015399803Contract manufacturerOrthopedic; General and plastic surgery; Neurology +3 moreMonument, CONot verifiedOct 21, 2026
MIDWEST STERILIZATION CORP.1928237Contract sterilizerGeneral and plastic surgery; Cardiovascular; General hospital +14 moreJackson, MONot verifiedOct 21, 2026
PRO-TECH DESIGN & MFG., INC.2032521Contract manufacturerOrthopedic; Cardiovascular; Neurology +9 moreSanta Fe Springs, CANot verifiedOct 21, 2026
QUALITY TECH SERVICES, LLC3003477135Contract manufacturerOrthopedic; General and plastic surgery; Neurology +11 moreBloomington, MNNot verifiedOct 21, 2026
Sterigenics Radiation Technologies, LLC2024024Contract sterilizerCardiovascular; General and plastic surgery; Dental +8 moreSan Diego, CANot verifiedOct 21, 2026
Sterigenics U.S. LLC1054811Contract sterilizerOrthopedic; General and plastic surgery; Ophthalmic +13 moreMulberry, FLNot verifiedOct 21, 2026
Sterigenics U.S., LLC1721676Contract sterilizerCardiovascular; Orthopedic; General and plastic surgery +12 moreSalt Lake City, UTNot 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
TECOMET1226425Contract manufacturerOrthopedic; Dental; Neurology +1 moreWoburn, MANot verifiedOct 21, 2026
Viant AS&O Holdings, LLC1218882Contract manufacturerOrthopedic; Neurology; General and plastic surgery +3 moreBrimfield, MANot verifiedOct 21, 2026

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