Ortho Solutions Inc

FDA Device Registration & Listing · Nashville, TN, US · Registration 3009812190

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
3009812190
FEI Number
3022270316
Entity Name
Ortho Solutions Inc
City/State/Country
Nashville, TN, US
Establishment Address
209 10th Avenue S, Ste. 416, Nashville, TN 37203, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
Owner / Operator
ORTHO SOLUTIONS INC (Owner Number: 10042129)
Owner / Operator Contact Address
Ortho Solutions, Unit 5, West Station Business Park, Spital Road, MALDON, GB-ESS CM9 6FF, GB
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

Succession AFN System ORTHO SOLUTIONS PLATING SYSTEM (Voliton Ankle Fracture) ORTHO SOLUTIONS COGNiTiON STAPLE SYSTEM ORTHO SOLUTIONS OXFORD ANKLE FUSION NAIL SYSTEM Volition Plating System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2025-08-11
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-10-25
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2021-10-25
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-10-25
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2025-01-20
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2012-10-23
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-10-25
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2021-10-25
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-10-25

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ORTHO SOLUTIONS INC
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
K040336 Synthes (Usa) SYNTHES (USA) LATERAL ENTRY FEMORAL NAIL SYSTEM 2004-04-12
K083648 Efratgo, Ltd. HI Tech Bio-Surgical GOTFRIED PHYSIOLOGICAL HIP (PH) NAIL 2009-05-14
K192312 Zimmer GmbH Zimmer Natural Nail System Cephalomedullary Nails 2019-10-11
K002057 Biomet Orthopedics, Inc. BROOKER TIBIA NAILS 2000-10-04
K062348 Medtronic Neurosurgery TIMESH SELF DRILLING SCREW 2006-09-08

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
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-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-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 3009812190. Last updated year: 2026. Please use registration number 3009812190 when referencing this establishment in official correspondence.
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