ARCH Medical Solutions - Warsaw

Contract manufacturer · Warsaw, IN

FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified

2012Product codes first listed, by year (tallest: 21)2026

FDA registration: 3009971621 (openFDA record; or search FDA's registration database)
FEI number: 3009971621
Registered for: FDA registration year 2026
Establishment types: Contract manufacturer
Owner or operator: Alpha Manufacturing & Design, LLC. (FDA owner/operator no. 10042381)
Registered address: 2070 N Cessna Rd, Warsaw, IN 46582
Contract listings: 70 device listings, 57 product codes, first listed Nov 21, 2012
Certification: Not verified. We have no certification data for this facility yet.

Devices listed as contract work

Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.

Product code	Device (FDA name)	Class	Category	Role	First listed
FSM	Tray, Surgical, Instrument	Class I	General and plastic surgery	Contract manufacturing	Aug 27, 2019
FTY	Tape, Measuring, Rulers And Calipers	Class I	General and plastic surgery	Contract manufacturing	Dec 27, 2018
FZO	Chisel, Surgical, Manual	Class I	General and plastic surgery	Contract manufacturing	Jan 17, 2023
FZT	Cutter, Surgical	Class I	General and plastic surgery	Contract manufacturing	Jul 13, 2023
FZX	Guide, Surgical, Instrument	Class I	General and plastic surgery	Contract manufacturing	May 7, 2019
FZY	Hammer, Surgical	Class I	General and plastic surgery	Contract manufacturing	Jan 17, 2023
GFG	Bit, Surgical	Class I	General and plastic surgery	Contract manufacturing	Jul 16, 2020
HRS	Plate, Fixation, Bone	Class II	Orthopedic	Contract manufacturing	Nov 21, 2012
HSB	Rod, Fixation, Intramedullary And Accessories	Class II	Orthopedic	Contract manufacturing	Jun 4, 2013
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Class II	Orthopedic	Contract manufacturing	Sep 19, 2019
HSN	Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer	Class II	Orthopedic	Contract manufacturing	Jan 23, 2013
HTD	Forceps	Class I	General and plastic surgery	Contract manufacturing	Jan 11, 2024
HTJ	Gauge, Depth	Class I	Orthopedic	Contract manufacturing	Nov 21, 2012
HTN	Washer, Bolt Nut	Class II	Orthopedic	Contract manufacturing	Jul 16, 2020
HTO	Reamer	Class I	Orthopedic	Contract manufacturing	Nov 21, 2012
HTW	Bit, Drill	Class I	Orthopedic	Contract manufacturing	Nov 21, 2012
HTX	Rongeur	Class I	Orthopedic	Contract manufacturing	Aug 25, 2021
HTY	Pin, Fixation, Smooth	Class II	Orthopedic	Contract manufacturing	Mar 26, 2019
HWA	Impactor	Class I	Orthopedic	Contract manufacturing	Nov 21, 2012
HWB	Extractor	Class I	Orthopedic	Contract manufacturing	Nov 21, 2012
HWC	Screw, Fixation, Bone	Class II	Orthopedic	Contract manufacturing	Nov 21, 2012
HWD	Starter, Bone Screw	Class I	Orthopedic	Contract manufacturing	Nov 21, 2012
HWN	Instrument, Compression	Class I	Orthopedic	Contract manufacturing	Sep 19, 2019
HWQ	Passer	Class I	Orthopedic	Contract manufacturing	Sep 19, 2019
HWR	Driver, Prosthesis	Class I	Orthopedic	Contract manufacturing	Nov 21, 2012
HWT	Template	Class I	Orthopedic	Contract manufacturing	Nov 21, 2012
HWW	Countersink	Class I	Orthopedic	Contract manufacturing	Nov 21, 2012
HWX	Tap, Bone	Class I	Orthopedic	Contract manufacturing	Nov 21, 2012
HXB	Probe	Class I	Orthopedic	Contract manufacturing	Aug 27, 2019
HXC	Wrench	Class I	Orthopedic	Contract manufacturing	Nov 21, 2012
HXD	Clamp	Class I	General and plastic surgery	Contract manufacturing	Apr 30, 2026
HXG	Tamp	Class I	Orthopedic	Contract manufacturing	Jul 13, 2023
HXI	Passer, Wire, Orthopedic	Class I	Orthopedic	Contract manufacturing	Nov 21, 2012
HXK	Holder, Needle; Orthopedic	Class I	Orthopedic	Contract manufacturing	May 22, 2013
HXL	Mallet	Class I	General and plastic surgery	Contract manufacturing	Jul 13, 2023
HXP	Instrument, Bending Or Contouring	Class I	Orthopedic	Contract manufacturing	Nov 21, 2012
HXW	Bender	Class I	Orthopedic	Contract manufacturing	Nov 21, 2012
HXX	Screwdriver	Class I	Orthopedic	Contract manufacturing	Nov 21, 2012
JDQ	Cerclage, Fixation	Class II	Orthopedic	Contract manufacturing	Jul 16, 2020
JDR	Staple, Fixation, Bone	Class II	Orthopedic	Contract manufacturing	Sep 25, 2024
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Class II	Orthopedic	Contract manufacturing	Aug 13, 2019
JWJ	Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained	Class II	Orthopedic	Contract manufacturing	Sep 24, 2024
KIJ	Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment	Class I	General and plastic surgery	Contract manufacturing	Sep 10, 2024
KIK	Hook, Bone	Class I	General and plastic surgery	Contract manufacturing	Aug 27, 2019
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Class II	Orthopedic	Contract manufacturing	Nov 21, 2012
KWP	Appliance, Fixation, Spinal Interlaminal	Class II	Orthopedic	Contract manufacturing	May 31, 2013
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Class II	Orthopedic	Contract manufacturing	Nov 21, 2012
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Class II	Orthopedic	Contract manufacturing	Sep 19, 2019
LXH	Orthopedic Manual Surgical Instrument	Class I	Orthopedic	Contract manufacturing	Nov 21, 2012
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Class II	Orthopedic	Contract manufacturing	Nov 21, 2012
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Class II	Orthopedic	Contract manufacturing	Jul 13, 2023
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Class II	Orthopedic	Contract manufacturing	Nov 23, 2016
MNI	Orthosis, Spinal Pedicle Fixation	Class II	Orthopedic	Contract manufacturing	Nov 23, 2016
NKB	Thoracolumbosacral Pedicle Screw System	Class II	Orthopedic	Contract manufacturing	Nov 23, 2016
OLO	Orthopedic Stereotaxic Instrument	Class II	Neurology	Contract manufacturing	Mar 3, 2022
OSH	Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	Class II	Orthopedic	Contract manufacturing	May 31, 2013
PHX	Shoulder Prosthesis, Reverse Configuration	Class II	Orthopedic	Contract manufacturing	Sep 12, 2024