Ortho Solutions UK Limited

FDA Device Registration & Listing · Maldon Essex, GB · Registration 3008951116

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
3008951116
FEI Number
3008951116
Entity Name
Ortho Solutions UK Limited
City/State/Country
Maldon Essex, GB
Establishment Address
West Station Business Park, Spital Road, Maldon Essex CM9 6FF, GB
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Ortho Solutions UK Ltd (Owner Number: 10035321)
Owner / Operator Contact Address
West Station Buisness Park, Spital Road, Maldon, GB-ESS CM96FF, GB
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

Oxford Ankle Fusion Nail (AFN) System Oxbridge Ankle Fusion Nail (AFN) System System 26 Headless Compression Cannulated Screws Twist-Off Screws System 26 Headed Compression Cannulated Screws System 26 Washer System Bone Plate/Screw/Washer - Mini Fragment (MFS) Bone Plate/Screw/Washer - Small Fragment (SFS) Systems Bone Plate/Screw/Washer - Large Fragment (LFS) CHS/SCS Compression Plate Cognition Staples Reamers Drill Bit Burr Saw Blade Reamer Ortho Solutions manual surgical instrument Volition Plating System Staples Compression Screw TwistFix Snap-Off Screws Systems Memo Staple Foot Plating (FPS) Meta Screw Foot Osteotomy (FOS) Extremity Fixation (EFS)

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 2012-09-27
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2017-03-14
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2017-03-14
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2012-08-10
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2012-08-10
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2012-08-10
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2012-08-10
HTW Bit, Drill Orthopedic Class 1 888.4540 2013-04-06
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2024-02-27
KIJ Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2023-01-12
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2023-01-24
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2023-01-12
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2021-06-23
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-06-23
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-06-23
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2012-02-16
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2012-02-16
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2012-02-16

Official Correspondent

Jesin Synthee

US Agent Details

Kevin Brothen Business: Ortho Solutions Inc Email: jesin.synthee@orthosol.com Phone: (480) 5400108

Related Public Records

Same Entity

Ortho Solutions UK Ltd
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-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 3008951116. Last updated year: 2026. Please use registration number 3008951116 when referencing this establishment in official correspondence.
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