Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016112537

FEI Number

3016112537

Entity Name

MAINSTREAM MEDICAL DEVICES

City/State/Country

Austin, TX, US

Establishment Address

3913 Todd Lane, Suites 304; 112, Austin, TX 78744, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Mainstream Medical Devices (Owner Number: 10061802)

Owner / Operator Contact Address

3913 Todd Lane, Suite 304, Austin, TX 78744, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Diamond Orthopedic Solar Mainstream Prytime HyperFlex Bunion Correction System Diamond Orthopedic Main-AXS Needle Leith Medical Impulse AM DeGen Medical Latitude C T-Fix 3Dsi VariLift Diamond Orthopedic Carlsmed Thoracic Innovations BlueBridge Open Chest Management System EVOLSi Elevation Spine Saber-C System Bone Solutions Spinal Simplicity Minuteman Graduated Tap Spinal Simplicity Patriot SI Posterior SI Joint Fusion Kit VariLift Get-Grin ClearCam Diamond Orthopedic Footbridge Medical HyperFlex Bunion Correction System Sterile Drill Bit - RMR Sterile Drill Bit VGI Medical SiJoin Baumann GRS Mainstream Mainstream Medical Surgical Knife primal OK SP Tightline

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2023-11-29
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2023-11-17
PHM	Intervertebral Fusion Device With Bone Graft, Thoracic	Orthopedic	Class 2	888.3080	2023-11-17
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2023-11-17
HWJ	Awl	Orthopedic	Class 1	888.4540	2023-07-12
OFC	Catheter Introducer Kit	Cardiovascular	Class 2	870.1340	2023-11-05
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2026-01-07
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2026-01-07
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2023-11-29
OCJ	Spinal Channeling Instrument, Vertebroplasty	Orthopedic	Class 1	888.4540	2024-11-22
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-01-12
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-01-12
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2023-11-09
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2022-09-26
OUR	Sacroiliac Joint Fixation	Orthopedic	Class 2	888.3040	2023-11-17
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2023-11-17
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2023-11-29
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2020-12-23
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2026-01-07
OUR	Sacroiliac Joint Fixation	Orthopedic	Class 2	888.3040	2023-11-17
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2026-05-15
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2026-05-15
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2026-05-15
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2022-01-13
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2023-11-17
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2021-05-17
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2022-01-13
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2023-11-29
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2026-01-07
KIJ	Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2024-08-06
OUR	Sacroiliac Joint Fixation	Orthopedic	Class 2	888.3040	2026-01-07
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2024-11-25
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2023-07-12
EMF	Knife, Surgical	General, Plastic Surgery	Class 1	878.4800	2019-11-20
PEK	Spinous Process Plate	Orthopedic	Class 2	888.3050	2023-11-17
FZO	Chisel, Surgical, Manual	General, Plastic Surgery	Class 1	878.4800	2020-05-14

Official Correspondent

Dana Wilcox

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Mainstream Medical Devices

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K223430	Life Spine, Inc.	ProLift Micro Expandable Spacer System	2023-05-04
K102293	Globus Medical, Inc.	CALIBER SPACER	2011-01-05
K193541	Nu Vasive, Incorporated	NuVasive Cohere Thoracolumbar Interbody System	2020-03-30
K080401	Advanced Medical Technologies AG	SHELL CAGE, WAVE CAGE, LOOP CAGE	2008-05-09
K200084	Zavation Medical Products, LLC	Zavation IBF System	2020-10-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0014-2014	Synthes USA HQ, Inc.	2	Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0026-2016	Ortho Solutions Inc 330 Franklin Tnpk	2	Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
Z-0027-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0043-2018	MicroPort Orthopedics Inc.	2	MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R Product Usage: MPO Total Hip Systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016112537. Last updated year: 2026. Please use registration number 3016112537 when referencing this establishment in official correspondence.