VERITAS MEDICAL DEVICES LLC

FDA Device Registration & Listing · Southlake, TX, US · Registration 3036042032

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3036042032
FEI Number
3036042032
Entity Name
VERITAS MEDICAL DEVICES LLC
City/State/Country
Southlake, TX, US
Establishment Address
251 E Southlake Blvd, Southlake, TX 76092, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
Owner / Operator
Veritas Medical Devices LLC (Owner Number: 10092794)
Owner / Operator Contact Address
251 E Southlake Blvd, Southlake, TX 76092, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

Jeil Medical FIX-C 3D Ti ACIF System Jeil Medical ARIX Cannulated Screw System Jeil Medical ARIX System Jeil Medical ARIX Ankle Distal Tibia System Jeil Medical FIX-C PEEK ACIF SA System Jeil Medical FIX-L PEEK PLIF and T-PLIF System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2026-02-02
NDG Washer, Bolt, Nut, Non-Spinal, Metallic Orthopedic Class 2 888.3030 2026-02-02
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2026-02-02
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2026-02-02
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2026-02-02
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2026-02-02
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2026-02-02
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2026-02-02
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2026-02-02

Official Correspondent

Jeff Gray

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Veritas Medical Devices LLC
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
K142269 Reliance Medical Systems, LLC Reliance Cervical IBF System 2015-06-09
K122085 Omni Surgical, LP Dba Spine360 STINGRAY CERVICAL CAGE 2012-10-17
K120275 Synthes (Usa), LLC SYNTHES ACIS/VERTEBRAL SPACER CR 2012-05-25
K062348 Medtronic Neurosurgery TIMESH SELF DRILLING SCREW 2006-09-08
K063244 Arc Surgical, LLC ARC SURGICAL BONE REDUCTION SCREW 2006-12-27

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 3036042032. Last updated year: 2026. Please use registration number 3036042032 when referencing this establishment in official correspondence.
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