ARCH Medical Solutions - Warsaw

FDA Device Registration & Listing · Warsaw, IN, US · Registration 3009971621

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
3009971621
FEI Number
3009971621
Entity Name
ARCH Medical Solutions - Warsaw
City/State/Country
Warsaw, IN, US
Establishment Address
2070 N Cessna Rd, Warsaw, IN 46582, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Alpha Manufacturing & Design, LLC. (Owner Number: 10042381)
Owner / Operator Contact Address
2070 North Cessna Road, Warsaw, IN 46582, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2020-07-16
JDQ Cerclage, Fixation Orthopedic Class 2 888.3010 2020-07-16
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2020-07-16
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2012-11-21
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2012-11-21
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2024-02-13
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2024-02-13
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2020-07-16
HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3110 2013-01-23
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2019-03-26
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2020-07-16
GFG Bit, Surgical General, Plastic Surgery Class 1 878.4820 2020-07-16
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2012-11-21
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2012-11-21
HXW Bender Orthopedic Class 1 888.4540 2012-11-21
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2012-11-21
HWN Instrument, Compression Orthopedic Class 1 888.4540 2019-09-19
HXL Mallet General, Plastic Surgery Class 1 878.4800 2023-07-13
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2012-11-21
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2012-11-21
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2016-11-23
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2016-11-23
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2016-11-23
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2016-11-23
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2016-11-23
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2016-11-23
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2022-03-03
HTW Bit, Drill Orthopedic Class 1 888.4540 2012-11-21
HWQ Passer Orthopedic Class 1 888.4540 2019-09-19
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2018-12-27
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2018-12-27
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2018-12-27
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2018-12-27
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2018-12-27
HTO Reamer Orthopedic Class 1 888.4540 2012-11-21
HWD Starter, Bone Screw Orthopedic Class 1 888.4540 2012-11-21
JWJ Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained Orthopedic Class 2 888.3800 2024-09-24
KIK Hook, Bone General, Plastic Surgery Class 1 878.4800 2019-08-27
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2023-01-19
HXG Tamp Orthopedic Class 1 888.4540 2023-07-13
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2012-11-21
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2012-11-21
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2020-07-16
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2019-08-13
HWB Extractor Orthopedic Class 1 888.4540 2012-11-21
FZY Hammer, Surgical General, Plastic Surgery Class 1 878.4800 2023-01-17
HTX Rongeur Orthopedic Class 1 888.4540 2021-08-25
HXK Holder, Needle; Orthopedic Orthopedic Class 1 888.4540 2013-05-22
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2012-11-21
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2012-11-21
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2013-06-04
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2012-11-21
HWA Impactor Orthopedic Class 1 888.4540 2012-11-21
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2020-07-16
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2020-07-16
HXD Clamp General, Plastic Surgery Class 1 878.4800 2026-04-30
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2012-11-21
HXX Screwdriver Orthopedic Class 1 888.4540 2012-11-21
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2013-05-31
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-05-31
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2012-11-21
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2018-12-27
HWT Template Orthopedic Class 1 888.4800 2012-11-21
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2019-09-19
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2019-09-19
HWW Countersink Orthopedic Class 1 888.4540 2012-11-21
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2024-09-12
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2020-04-22
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-06-04
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2013-06-04
HTJ Gauge, Depth Orthopedic Class 1 888.4300 2012-11-21
HXI Passer, Wire, Orthopedic Orthopedic Class 1 888.4540 2012-11-21
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2020-07-16
FZT Cutter, Surgical General, Plastic Surgery Class 1 878.4800 2023-07-13
HTD Forceps General, Plastic Surgery Class 1 878.4800 2024-01-11
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2023-07-13
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2020-07-16
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2012-11-21
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2012-11-21
HXC Wrench Orthopedic Class 1 888.4540 2012-11-21
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2020-07-16
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2020-07-16
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2019-05-07
FTY Tape, Measuring, Rulers And Calipers General, Plastic Surgery Class 1 878.4800 2018-12-27
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2019-09-19
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2019-09-19

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Alpha Manufacturing & Design, 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
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

Similar Registrations

Registration Number Establishment Name Location
3013843055 BEIJING AK MEDICAL CO, LTD Changping District Beijing, CN
3022777867 FIXIER S.A. DE C.V. Doctor Mora Guanajuato, MX
3017209758 NEBULA SURGICAL PRIVATE LIMITED Rajkot Gujarat, IN
3015410662 Jabil Inc. (Wilson Drive) W Chester, PA, US
8043862 AAP IMPLANTATE AG BERLIN, DE
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009971621. Last updated year: 2026. Please use registration number 3009971621 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.