MedtechSourcebook

Board, Arm (With Cover), Sterile (BTX) contract manufacturers

5 US facilities list FDA product code BTX as a contract manufacturer (0) or contract sterilizer (5).

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

FDA device name
Board, Arm (With Cover), Sterile
Product code
BTX (FDA product classification database)
Device class
Class I
Regulation
21 CFR 878.3910
Classification panel
General and plastic surgery

Where they are

California 3 · Illinois 2

All 5 facilities

CompanyFDA registrationEstablishment typeDevice categoriesCity and stateCertificationUpdated
BIOSEAL2027062Contract sterilizerGeneral and plastic surgery; General hospital; Orthopedic +12 morePlacentia, CANot verifiedOct 21, 2026
Isomedix Operations, Inc2032098Contract sterilizerOrthopedic; General and plastic surgery; General hospital +12 moreOntario, CANot verifiedOct 21, 2026
Isomedix Operations, Inc.1424263Contract sterilizerOrthopedic; General and plastic surgery; Ophthalmic +13 moreLibertyville, ILNot verifiedOct 21, 2026
Isomedix Operations, Inc.1450662Contract sterilizerOrthopedic; General and plastic surgery; Cardiovascular +11 moreLibertyville, ILNot verifiedOct 21, 2026
Sterigenics U.S., LLC2029275Contract sterilizerGeneral and plastic surgery; Orthopedic; Cardiovascular +16 moreCorona, CANot verifiedOct 21, 2026

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