MedtechSourcebook

MAINSTREAM MEDICAL DEVICES

Contract manufacturer and sterilizer ยท Austin, TX

FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified

2020Product codes first listed, by year (tallest: 11)2026
FDA registration
3016112537 (openFDA record; or search FDA's registration database)
FEI number
3016112537
Registered for
FDA registration year 2026
Establishment types
Complaint file establishment; Manufacturer; Contract manufacturer; Contract sterilizer
Owner or operator
Mainstream Medical Devices (FDA owner/operator no. 10061802)
Registered address
3913 Todd Lane, Suites 304; 112, Austin, TX 78744
Contract listings
35 device listings, 29 product codes, first listed May 14, 2020
Certification
Not verified. We have no certification data for this facility yet.

Devices listed as contract work

Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.

Product codeDevice (FDA name)ClassCategoryRoleFirst listed
DZNInstruments, Dental HandClass IDentalContract manufacturingMay 17, 2021
FZOChisel, Surgical, ManualClass IGeneral and plastic surgeryContract manufacturingMay 14, 2020
GADRetractorClass IGeneral and plastic surgeryContract manufacturingJan 7, 2026
GCJLaparoscope, General & Plastic SurgeryClass IIGastroenterology and urologyContract manufacturingJan 13, 2022
GEACannula, Surgical, General & Plastic SurgeryClass IGeneral and plastic surgeryContract manufacturingJul 12, 2023
HAERongeur, ManualClass IINeurologyContract manufacturingJun 19, 2026
HRSPlate, Fixation, BoneClass IIOrthopedicContract manufacturingJan 12, 2022
HRXArthroscopeClass IIOrthopedicContract manufacturingJun 19, 2026
HTJGauge, DepthClass IOrthopedicContract manufacturingNov 29, 2023
HTWBit, DrillClass IOrthopedicContract manufacturingNov 29, 2023
HTYPin, Fixation, SmoothClass IIOrthopedicContract manufacturingNov 29, 2023
HWCScrew, Fixation, BoneClass IIOrthopedicContract manufacturingJan 12, 2022
HWJAwlClass IOrthopedicContract manufacturingJul 12, 2023
HXLMalletClass IGeneral and plastic surgeryContract manufacturingApr 1, 2025
HXXScrewdriverClass IOrthopedicContract manufacturingNov 29, 2023
KIJInstrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/AttachmentClass IGeneral and plastic surgeryContract manufacturingAug 6, 2024
KWQAppliance, Fixation, Spinal Intervertebral BodyClass IIOrthopedicContract manufacturingMay 15, 2026
LXHOrthopedic Manual Surgical InstrumentClass IOrthopedicContract manufacturingJan 13, 2022
MAXIntervertebral Fusion Device With Bone Graft, LumbarClass IIOrthopedicContract manufacturingDec 23, 2020
MAXIntervertebral Fusion Device With Bone Graft, LumbarClass IIOrthopedicContract sterilizationDec 23, 2020
MDMInstrument, Manual, Surgical, General UseClass IGeneral and plastic surgeryContract manufacturingNov 25, 2024
OCJSpinal Channeling Instrument, VertebroplastyClass IOrthopedicContract manufacturingNov 22, 2024
ODPIntervertebral Fusion Device With Bone Graft, CervicalClass IIOrthopedicContract manufacturingSep 26, 2022
OFCCatheter Introducer KitClass IICardiovascularContract manufacturingNov 5, 2023
OURSacroiliac Joint FixationClass IIOrthopedicContract manufacturingSep 26, 2022
OVDIntervertebral Fusion Device With Integrated Fixation, LumbarClass IIOrthopedicContract manufacturingNov 9, 2023
OVEIntervertebral Fusion Device With Integrated Fixation, CervicalClass IIOrthopedicContract manufacturingMay 15, 2026
PEKSpinous Process PlateClass IIOrthopedicContract manufacturingNov 17, 2023
PHMIntervertebral Fusion Device With Bone Graft, ThoracicClass IIOrthopedicContract manufacturingNov 9, 2023
PXBPercutaneous Introducer KitClass IIGeneral hospitalContract manufacturingNov 5, 2023