MedtechSourcebook

Prosthesis, Wrist, Hemi-, Ulnar (KXE) contract manufacturers

14 US facilities list FDA product code KXE as a contract manufacturer (12) or contract sterilizer (2).

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

FDA device name
Prosthesis, Wrist, Hemi-, Ulnar
Product code
KXE (FDA product classification database)
Device class
Class II
Regulation
21 CFR 888.3810
Classification panel
Orthopedic
FDA flags
implant

Where they are

California 3 · Minnesota 3 · Texas 3 · Indiana 1 · Massachusetts 1 · Michigan 1 · New Jersey 1 · Pennsylvania 1

All 14 facilities

CompanyFDA registrationEstablishment typeDevice categoriesCity and stateCertificationUpdated
ARCH - Quakertown2531477Contract manufacturerOrthopedic; General and plastic surgery; NeurologyQuakertown, PANot verifiedOct 21, 2026
BANISTER TOOL, INC.1649379Contract manufacturerOrthopedic; General and plastic surgery; DentalPflugerville, TXNot verifiedOct 21, 2026
Isomedix Operations, Inc.2030624Contract sterilizerCardiovascular; General and plastic surgery; Gastroenterology and urology +11 moreTemecula, CANot verifiedOct 21, 2026
MILLSTONE MEDICAL OUTSOURCING LLC.1226544Contract manufacturerOrthopedic; General and plastic surgery; Neurology +7 moreFall River, MANot verifiedOct 21, 2026
ORCHID UNIQUE1828288Contract manufacturerOrthopedic; General and plastic surgery; Dental +3 moreBridgeport, MINot verifiedOct 21, 2026
PARAGON MEDICAL, INC.1834331Contract manufacturerOrthopedic; General and plastic surgery; Neurology +4 morePierceton, INNot verifiedOct 21, 2026
Phillips Precision Inc3003387384Contract manufacturerOrthopedic; General and plastic surgery; NeurologyElmwood Park, NJNot verifiedOct 21, 2026
PRO-TECH Design & Mfg, Inc.3013023969Contract manufacturerNeurology; Physical medicine; Gastroenterology and urology +3 moreSanta Fe Springs, CANot 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
RMS CO.2183946Contract manufacturerOrthopedic; Neurology; General and plastic surgery +4 moreMinneapolis, MNNot verifiedOct 21, 2026
Sterigenics US LLC1649518Contract sterilizerOrthopedic; General and plastic surgery; General hospital +13 moreFort Worth, TXNot verifiedOct 21, 2026
SURGICAL TECHNOLOGIES, INC.2183319Contract manufacturerGeneral and plastic surgery; Cardiovascular; Ear, nose and throat +5 moreSt. Paul, MNNot verifiedOct 21, 2026
TURNCO TOOL & INSTRUMENT, INC.3009241418Contract manufacturerOrthopedic; General and plastic surgery; Dental +1 moreGeorgetown, TXNot verifiedOct 21, 2026

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