Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1424434

FEI Number

3002795782

Entity Name

ARCH Medical Solutions - Elmhurst

City/State/Country

Elmhurst, IL, US

Establishment Address

612 W Lamont Rd, Elmhurst, IL 60126, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

MedTorque, Inc. (Owner Number: 9038612)

Owner / Operator Contact Address

612 Lamont Road, --, Elmhurst, IL 60126, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

none available NONE AVAILABLE PRESTIGE LP CERVICAL DISC STREAMLINED INSTRUMENTS NONE AVAILABLE n/a NONE AVAILABLE NONE AVAILABLE NONE AVAILABLE NONE AVAILABLE NONE AVAILABLE NONE AVAILABLE NONE AVAILABLE NONE AVAILABLE NONE AVAILABLE NONE AVAILABLE NONE AVAILABLE NONE AVAILABLE NONE AVAILABLE NONE AVAILABLE NONE AVAILABLE NONE AVAILABLE none available intervertebral fusion device with bone graft, lumbar NONE AVAILABLE NONE AVAILABLE NONE AVAILABLE NONE AVAILABLE NONE AVAILABLE NONE AVAILABLE NONE AVAILABLE NONE AVAILABLE Robotic Graft Delivery Instruments NONE AVAILABLE orthopedic stereotaxic instrument NONE AVAILABLE NONE AVAILABLE NONE AVAILABLE NONE AVAILABLE NONE AVAILABLE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HXB	Probe	Orthopedic	Class 1	888.4540	2016-11-18
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2013-02-04
MJO	Prosthesis, Intervertebral Disc	Unknown	Class 3	N/A	2023-11-27
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2013-02-04
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2018-06-04
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2018-06-04
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2023-07-26
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2016-11-18
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2013-02-04
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2013-02-04
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2013-02-04
FZO	Chisel, Surgical, Manual	General, Plastic Surgery	Class 1	878.4800	2016-12-28
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2016-12-28
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2013-02-04
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2013-02-04
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2013-02-04
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2013-02-04
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2013-02-04
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2013-02-04
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2013-02-21
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2013-02-04
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2013-02-04
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2013-02-04
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2013-02-04
HSN	Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3110	2013-02-04
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2013-02-04
HWB	Extractor	Orthopedic	Class 1	888.4540	2016-12-28
NQW	Orthosis, Spine, Plate, Laminoplasty, Metal	Orthopedic	Class 2	888.3050	2013-02-04
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2018-06-04
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2018-06-04
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2013-02-04
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2018-11-27
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2018-11-27
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2023-08-31
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2023-08-31
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2023-08-31
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-02-04
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2013-02-04
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2013-02-04
JDW	Pin, Fixation, Threaded	Orthopedic	Class 2	888.3040	2013-02-04
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2013-02-04
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2016-12-28
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-02-04
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2013-02-04
HSN	Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3110	2013-02-04
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2013-02-04
HWA	Impactor	Orthopedic	Class 1	888.4540	2018-06-04
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2013-02-04
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2013-02-04
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2013-02-04
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2013-02-04
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2023-07-26
HXW	Bender	Orthopedic	Class 1	888.4540	2016-11-22
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2023-12-20
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2013-02-04
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2023-07-24
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2013-02-04
OYK	Ankle Arthroplasty Implantation System	Orthopedic	Class 2	888.3110	2013-02-04
HSN	Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3110	2013-02-04
HXP	Instrument, Bending Or Contouring	Orthopedic	Class 1	888.4540	2018-06-04
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2016-12-28
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2013-02-04

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
K963639	Acromed Corp.	ACROMED PEDICLE SCREW	1996-11-14
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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0026-2011	Zimmer Inc.	2	SpeedLink 5.5 Transverse Connector Short 39.5-44mm, non-sterile, 1302-55S
Z-0027-2011	Zimmer Inc.	2	SpeedLink 5.5 Transverse Connector Medium 43-51mm, non-sterile, 1302-55M
Z-0028-2011	Zimmer Inc.	2	SpeedLink 5.5 Transverse Connector Long 50-65mm, non-sterile, 1302-55L
Z-0029-2011	Zimmer Inc.	2	SpeedLink 5.5 Transverse Connector X-Long 60-75mm, non-sterile, 1302-55XL
Z-0030-2011	Zimmer Inc.	2	SpeedLink 6.0 Transverse Connector Short 39.5-44mm, non-sterile, 1304-60S

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1424434. Last updated year: 2026. Please use registration number 1424434 when referencing this establishment in official correspondence.