ARCH-MedTorque

FDA Device Registration & Listing · Kenosha, WI, US · Registration 3005874553

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
3005874553
FEI Number
3005874553
Entity Name
ARCH-MedTorque
City/State/Country
Kenosha, WI, US
Establishment Address
5601 95th Ave, Kenosha, WI 53144, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
MEDTORQUE, INC. (Owner Number: 9069996)
Owner / Operator Contact Address
5601 95th Avenue, --, Kenosha, WI 53144, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

NONE AVAILABLE NONE AVAILABLE NONE AVAILABLE CURETTE NONE AVAILABLE NONE AVAILABLE Wrench PROBE NONE AVAILABLE IMPACTOR NONE AVAILABLE SCREWDRIVER NONE AVAILABLE INSTRUMENT, MANUAL, SURGICAL, GENERAL USE Osteotome Orthopedic manual surgical instrument NONE AVAILABLE INSTRUMENT, SURGICAL, DISPOSABLE

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2025-01-23
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2025-01-23
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2025-01-23
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-01-23
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2025-01-23
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2025-01-23
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2025-01-23
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2025-01-23
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2013-10-25
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2013-10-25
OOG Knee Arthroplasty Implantation System Orthopedic Class 2 888.3560 2013-10-25
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2013-10-25
HWX Tap, Bone Orthopedic Class 1 888.4540 2013-01-26
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2025-01-23
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2025-01-23
JDS Nail, Fixation, Bone Orthopedic Class 2 888.3030 2025-01-23
HTF Curette General, Plastic Surgery Class 1 878.4800 2021-06-07
NBH Accessories, Arthroscopic Orthopedic Class 1 888.1100 2013-02-04
HTE Elevator General, Plastic Surgery Class 1 878.4800 2018-01-11
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2025-01-23
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2025-01-23
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-01-23
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2025-01-23
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2025-01-23
HXC Wrench Orthopedic Class 1 888.4540 2013-01-26
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2025-01-23
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2025-01-23
HXB Probe Orthopedic Class 1 888.4540 2018-02-13
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-01-23
HXW Bender Orthopedic Class 1 888.4540 2013-01-26
HWA Impactor Orthopedic Class 1 888.4540 2021-06-07
HWJ Awl Orthopedic Class 1 888.4540 2013-01-26
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2025-01-23
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2025-01-23
HXX Screwdriver Orthopedic Class 1 888.4540 2015-09-23
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2025-01-23
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2025-01-23
JDS Nail, Fixation, Bone Orthopedic Class 2 888.3030 2025-01-23
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2025-01-23
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2025-01-23
GFI Osteotome, Manual General, Plastic Surgery Class 1 878.4800 2013-01-26
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-01-23
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2025-01-23
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2023-07-25
HWM Osteotome General, Plastic Surgery Class 1 878.4800 2017-12-29
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2012-11-20
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-01-23
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2025-01-23
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-01-23
HTW Bit, Drill Orthopedic Class 1 888.4540 2013-01-26
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2025-01-23
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2025-01-23
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2025-01-23
KDC Instrument, Surgical, Disposable General, Plastic Surgery Class 1 878.4800 2023-07-25

Official Correspondent

APRIL SCHULTZ

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MEDTORQUE, 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
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
K082949 OrthoPediatrics Corp. ORTHOPEDIATRICS BONE SCREWS 2008-11-25

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 3005874553. Last updated year: 2026. Please use registration number 3005874553 when referencing this establishment in official correspondence.
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