NGInstruments, Inc dba Avalign Cutting Instruments

Contract manufacturer · Warsaw, IN

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

2013Product codes first listed, by year (tallest: 30)2026

FDA registration: 1835251 (openFDA record; or search FDA's registration database)
FEI number: 3000205591
Registered for: FDA registration year 2026
Establishment types: Contract manufacturer
Owner or operator: NG Instruments, Inc dba Avalign Cutting Instruments (FDA owner/operator no. 10042855)
Registered address: 4643 N State Road 15, Warsaw, IN 46582
Contract listings: 118 device listings, 77 product codes, first listed Jan 7, 2013
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
EML	Chisel, Bone, Surgical	Class I	Dental	Contract manufacturing	Dec 31, 2014
FZX	Guide, Surgical, Instrument	Class I	General and plastic surgery	Contract manufacturing	Dec 31, 2014
GAD	Retractor	Class I	General and plastic surgery	Contract manufacturing	Jan 31, 2013
GFA	Blade, Saw, General & Plastic Surgery, Surgical	Class I	General and plastic surgery	Contract manufacturing	Sep 12, 2017
GFF	Bur, Surgical, General & Plastic Surgery	Class I	General and plastic surgery	Contract manufacturing	Jan 31, 2013
GFG	Bit, Surgical	Class I	General and plastic surgery	Contract manufacturing	Jun 22, 2023
GWF	Stimulator, Electrical, Evoked Response	Class II	Neurology	Contract manufacturing	Jan 7, 2013
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Class II	Neurology	Contract manufacturing	Jan 7, 2013
HRS	Plate, Fixation, Bone	Class II	Orthopedic	Contract manufacturing	Jan 31, 2013
HSB	Rod, Fixation, Intramedullary And Accessories	Class II	Orthopedic	Contract manufacturing	Dec 23, 2013
HSN	Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer	Class II	Orthopedic	Contract manufacturing	Jan 31, 2013
HTC	Pliers, Surgical	Class I	General and plastic surgery	Contract manufacturing	Aug 17, 2018
HTD	Forceps	Class I	General and plastic surgery	Contract manufacturing	Jan 31, 2013
HTN	Washer, Bolt Nut	Class II	Orthopedic	Contract manufacturing	Dec 24, 2014
HTO	Reamer	Class I	Orthopedic	Contract manufacturing	Jan 31, 2013
HTR	Rasp	Class I	General and plastic surgery	Contract manufacturing	Jan 31, 2013
HTW	Bit, Drill	Class I	Orthopedic	Contract manufacturing	Jan 31, 2013
HTZ	Instrument, Cutting, Orthopedic	Class I	General and plastic surgery	Contract manufacturing	Jan 10, 2015
HWB	Extractor	Class I	Orthopedic	Contract manufacturing	Jan 31, 2013
HWC	Screw, Fixation, Bone	Class II	Orthopedic	Contract manufacturing	Jan 31, 2013
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	Class I	General and plastic surgery	Contract manufacturing	Jan 7, 2013
HWJ	Awl	Class I	Orthopedic	Contract manufacturing	Jan 31, 2013
HWT	Template	Class I	Orthopedic	Contract manufacturing	Jan 31, 2013
HWW	Countersink	Class I	Orthopedic	Contract manufacturing	Feb 4, 2013
HWX	Tap, Bone	Class I	Orthopedic	Contract manufacturing	Jan 31, 2013
HXB	Probe	Class I	Orthopedic	Contract manufacturing	Jan 31, 2013
HXC	Wrench	Class I	Orthopedic	Contract manufacturing	Jan 31, 2013
HXD	Clamp	Class I	General and plastic surgery	Contract manufacturing	Nov 5, 2018
HXI	Passer, Wire, Orthopedic	Class I	Orthopedic	Contract manufacturing	Jan 10, 2015
HXT	Tape, Orthopedic	Class I	General and plastic surgery	Contract manufacturing	Jan 31, 2013
HXX	Screwdriver	Class I	Orthopedic	Contract manufacturing	Jan 31, 2013
JDC	Prosthesis, Elbow, Constrained, Cemented	Class II	Orthopedic	Contract manufacturing	Jun 19, 2018
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Class II	Orthopedic	Contract manufacturing	Mar 28, 2022
JDO	Device, Fixation, Proximal Femoral, Implant	Class II	Orthopedic	Contract manufacturing	Nov 19, 2015
JDS	Nail, Fixation, Bone	Class II	Orthopedic	Contract manufacturing	Dec 23, 2013
JDW	Pin, Fixation, Threaded	Class II	Orthopedic	Contract manufacturing	May 18, 2020
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Class II	Orthopedic	Contract manufacturing	Jan 23, 2014
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	Class II	General hospital	Contract manufacturing	Jan 28, 2026
KIJ	Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment	Class I	General and plastic surgery	Contract manufacturing	Apr 29, 2025
KRO	Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer	Class II	Orthopedic	Contract manufacturing	Mar 28, 2023
KRR	Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer	Class II	Orthopedic	Contract manufacturing	May 10, 2023
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Class II	Orthopedic	Contract manufacturing	Dec 24, 2014
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Class II	Orthopedic	Contract manufacturing	Apr 20, 2016
KWP	Appliance, Fixation, Spinal Interlaminal	Class II	Orthopedic	Contract manufacturing	Jan 31, 2013
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Class II	Orthopedic	Contract manufacturing	Jan 31, 2013
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Class II	Orthopedic	Contract manufacturing	Apr 20, 2016
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Class II	Orthopedic	Contract manufacturing	Mar 28, 2022
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Class II	Orthopedic	Contract manufacturing	Dec 24, 2014
LXH	Orthopedic Manual Surgical Instrument	Class I	Orthopedic	Contract manufacturing	Jan 31, 2013
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Class II	Orthopedic	Contract manufacturing	Dec 24, 2014
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Class II	Orthopedic	Contract manufacturing	Nov 1, 2022
MAY	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish	Class II	Orthopedic	Contract manufacturing	Mar 28, 2022
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Class II	Orthopedic	Contract manufacturing	Jan 23, 2014
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Class II	Orthopedic	Contract manufacturing	Apr 3, 2019
MBL	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous	Class II	Orthopedic	Contract manufacturing	Mar 28, 2022
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Class II	Orthopedic	Contract manufacturing	Apr 20, 2016
MJO	Prosthesis, Intervertebral Disc	Class III	Orthopedic	Contract manufacturing	Jan 24, 2025
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Class II	Orthopedic	Contract manufacturing	Jan 31, 2013
MNI	Orthosis, Spinal Pedicle Fixation	Class II	Orthopedic	Contract manufacturing	Jan 31, 2013
MRW	System, Facet Screw Spinal Device	Unclassified	Orthopedic	Contract manufacturing	Jan 31, 2013
NBH	Accessories, Arthroscopic	Class I	Orthopedic	Contract manufacturing	Nov 19, 2015
NKB	Thoracolumbosacral Pedicle Screw System	Class II	Orthopedic	Contract manufacturing	Jan 31, 2013
NKG	Posterior Cervical Screw System	Class II	Orthopedic	Contract manufacturing	Jan 28, 2022
NQW	Orthosis, Spine, Plate, Laminoplasty, Metal	Class II	Orthopedic	Contract manufacturing	Jan 29, 2026
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Class II	Orthopedic	Contract manufacturing	Jan 29, 2026
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Class II	Orthopedic	Contract manufacturing	Dec 24, 2014
OLO	Orthopedic Stereotaxic Instrument	Class II	Neurology	Contract manufacturing	Jan 28, 2022
OQG	Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented	Class II	Orthopedic	Contract manufacturing	Dec 24, 2014
OQI	Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented	Class II	Orthopedic	Contract manufacturing	Dec 24, 2014
OSH	Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	Class II	Orthopedic	Contract manufacturing	Jan 28, 2026
OUR	Sacroiliac Joint Fixation	Class II	Orthopedic	Contract manufacturing	Dec 30, 2014
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Class II	Orthopedic	Contract manufacturing	Dec 24, 2014
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Class II	Orthopedic	Contract manufacturing	Jan 7, 2015
OWB	Interventional Fluoroscopic X-Ray System	Class II	Radiology	Contract manufacturing	Jan 29, 2026
OWI	Bone Fixation Cerclage, Sublaminar	Class II	Orthopedic	Contract manufacturing	Jan 29, 2026
PGN	Growing Rod System- Magnetic Actuation	Class II	Orthopedic	Contract manufacturing	Jan 29, 2026
PML	Bone Cement, Posterior Screw Augmentation	Class II	Orthopedic	Contract manufacturing	Jan 29, 2026