FUSION ORTHOPEDICS USA, LLC

FDA Device Registration & Listing · Mesa, AZ, US · Registration 3013365802

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
3013365802
FEI Number
3013365802
Entity Name
FUSION ORTHOPEDICS USA, LLC
City/State/Country
Mesa, AZ, US
Establishment Address
6859 E Rembrandt Ave, Ste 122, Mesa, AZ 85212, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
Owner / Operator
Fusion Orthopedics, LLC. (Owner Number: 10053147)
Owner / Operator Contact Address
4135 S Power Rd., Suite 110, Mesa, AZ 85212, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

Revolution External Plating System Lundeen Subtalar System TalarLift STS Revolution External Plating System Trial Sizers Bolo Button SGARLATO LESSER TOE IMPLANT HammerTech FuzeFix Screw System FuzeFix Large FuzeFix Mini FuzeFix Max FT FuzeFix Twist Off FibFix Nail

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2025-02-28
MJW Prosthesis, Subtalar, Plug, Polymer Orthopedic Class 2 888.3040 2019-02-12
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2020-05-04
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2020-05-04
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2017-10-31
HTO Reamer Orthopedic Class 1 888.4540 2020-06-18
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2025-02-28
HWT Template Orthopedic Class 1 888.4800 2026-02-20
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2025-01-20
KWH Prosthesis, Toe, Constrained, Polymer Orthopedic Class 2 888.3720 2019-02-12
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2018-12-07
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2018-12-07
HTJ Gauge, Depth Orthopedic Class 1 888.4300 2026-02-19
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2017-10-31
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-10-28
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2020-12-18
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2026-03-25
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2025-08-27

Official Correspondent

Adam Cundiff

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Fusion Orthopedics, 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
K033476 Howmedica Osteonics Corp. MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM 2004-01-20
K062348 Medtronic Neurosurgery TIMESH SELF DRILLING SCREW 2006-09-08
K063244 Arc Surgical, LLC ARC SURGICAL BONE REDUCTION SCREW 2006-12-27
K972722 Orthopedic Designs, Inc. ULTIMATE COMPRESSION SCREW SYSTEM 1998-01-23
K192974 Tyber Medical, LLC Tyber Medical Trauma Screw 2020-01-08

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 3013365802. Last updated year: 2026. Please use registration number 3013365802 when referencing this establishment in official correspondence.
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