ARTFX MEDICAL LLC

FDA Device Registration & Listing · JAX, FL, US · Registration 3017435639

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
3017435639
FEI Number
3017435639
Entity Name
ARTFX MEDICAL LLC
City/State/Country
JAX, FL, US
Establishment Address
50 n laura st 25th floor, JAX, FL 32202, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
ARTFX MEDICAL LLC (Owner Number: 10077845)
Owner / Operator Contact Address
50 N laura st 25th floor, Jacksonville, FL 32202, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

ARTFX SPINE INSTRUMENT ARTFX SPINE INSTRUMENT ARTFX Lumbar Cages Artfx Trauma system ARTFX ARTHROSCOPY ARTFX SPINAL SYSTEM ARTFX SPINAL FIXATION SYSTEM ARTFX NAIL SYSTEM ARTFX TRAUMA INSTRUMENT ARTX Cervical Peek Cage ARTFX TRAUMA INSTRUMENT

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LYQ Accessories, Fixation, Spinal Intervertebral Body Orthopedic Class 1 888.4540 2021-02-19
HAO Instrument, Surgical, Non-Powered Neurology Class 1 882.4535 2021-01-24
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-01-10
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-09-13
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2023-09-13
NBH Accessories, Arthroscopic Orthopedic Class 1 888.1100 2025-01-15
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2023-09-25
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2023-09-25
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2023-06-07
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2023-06-07
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2023-06-07
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2023-09-25
HXP Instrument, Bending Or Contouring Orthopedic Class 1 888.4540 2021-01-24
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2025-01-10
HAO Instrument, Surgical, Non-Powered Neurology Class 1 882.4535 2021-01-24
HWN Instrument, Compression Orthopedic Class 1 888.4540 2021-01-24

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ARTFX MEDICAL 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
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 3017435639. Last updated year: 2026. Please use registration number 3017435639 when referencing this establishment in official correspondence.
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