MedtechSourcebook

Prosthesis, Toe, Constrained, Polymer (KWH) contract manufacturers

14 US facilities list FDA product code KWH as a contract manufacturer (5) or contract sterilizer (9).

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

FDA device name
Prosthesis, Toe, Constrained, Polymer
Product code
KWH (FDA product classification database)
Device class
Class II
Regulation
21 CFR 888.3720
Classification panel
Orthopedic
FDA flags
implant

Where they are

Illinois 3 · Minnesota 2 · Arizona 1 · Connecticut 1 · Georgia 1 · Indiana 1 · Michigan 1 · New Jersey 1 · Ohio 1 · Pennsylvania 1 · Texas 1

All 14 facilities

CompanyFDA registrationEstablishment typeDevice categoriesCity and stateCertificationUpdated
Isomedix Operations Inc.2246552Contract sterilizerGeneral and plastic surgery; Orthopedic; Gastroenterology and urology +12 moreS Plainfield, NJNot 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
Isomedix Operations, Inc.2183744Contract sterilizerCardiovascular; General and plastic surgery; Gastroenterology and urology +13 moreMinneapolis, MNNot verifiedOct 21, 2026
MEDICAL DEVICE AND IMPLANTS LLC3009826895Contract manufacturerOrthopedicLancaster, PANot verifiedOct 21, 2026
MICROPULSE INC1834379Contract manufacturerOrthopedic; General and plastic surgery; Neurology +1 moreColumbia City, INNot verifiedOct 21, 2026
ORCHID UNIQUE1828288Contract manufacturerOrthopedic; General and plastic surgery; Dental +3 moreBridgeport, MINot verifiedOct 21, 2026
QUALITY TECH SERVICES, LLC3003477135Contract manufacturerOrthopedic; General and plastic surgery; Neurology +11 moreBloomington, MNNot verifiedOct 21, 2026
R.K. Manufacturing1226146Contract manufacturerOrthopedic; General and plastic surgery; Gastroenterology and urology +3 moreDanbury, CTNot verifiedOct 21, 2026
Sterigenics U.S., LLC1018470Contract sterilizerGeneral and plastic surgery; Orthopedic; General hospital +12 moreAtlanta, GANot verifiedOct 21, 2026
Sterigenics US LLC1423662Contract sterilizerOrthopedic; General and plastic surgery; General hospital +14 moreGurnee, ILNot verifiedOct 21, 2026
Sterigenics US LLC1649518Contract sterilizerOrthopedic; General and plastic surgery; General hospital +13 moreFort Worth, TXNot verifiedOct 21, 2026
Sterigenics US, LLC1526534Contract sterilizerOrthopedic; General and plastic surgery; General hospital +14 moreLewis Center, OHNot verifiedOct 21, 2026
Stryker Sustainability Solutions Phoenix2090040Contract sterilizerOrthopedic; General and plastic surgery; General hospitalPhoenix, AZNot verifiedOct 21, 2026

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