Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1835251

FEI Number

3000205591

Entity Name

NGInstruments, Inc dba Avalign Cutting Instruments

City/State/Country

Warsaw, IN, US

Establishment Address

4643 N State Road 15, Warsaw, IN 46582, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

NG Instruments, Inc dba Avalign Cutting Instruments (Owner Number: 10042855)

Owner / Operator Contact Address

4643 North State Road 15, Warsaw, IN 46582, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Probe Retractor A400 Hip System Reamer Infinity Total Ankle System Bone Pin Guide Pin Bur, Surgical Excella MIS Spinal System - Innovasis "Femoral Epidrill, Patellar Epidrill" Flexible Reamer Shaft Tap, Bone Smith and Nephew JET-X Actis Flexible Distal Reamers Snowcap Drill Bit TENACULUM CLAMP Certex Spinal Implant System - XSpine Zimmer Nexel Total Elbow MTP Cup Reamer Wrench Zimmer Biomet Femoral Aimer Guide Pins Lineum Renovis CS System Zavation Spine System IPC Powerease system Triathlon DePuy Drill Sleeve 2.4/3.2/4MM Opteryx Cervical Plate System - Innovasis ZIMMER BIOMET M/G UNI HOLDING PIN PLIERS Extractor Forceps Nail & Rod Fixation Awl Plate, Fixation, Bone Rasp Centurion POCTSystem - OrthoFix Spherical Cutter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2013-01-31
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2013-01-31
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2013-01-31
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2026-01-29
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2026-01-29
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2026-01-29
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2024-09-10
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2026-01-29
HXB	Probe	Orthopedic	Class 1	888.4540	2013-01-31
KIJ	Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2025-04-29
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2026-01-29
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2026-01-27
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2013-01-31
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2026-01-29
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2013-01-31
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2013-01-31
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2013-01-31
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2013-01-31
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2013-01-31
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2026-01-29
OQG	Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented	Orthopedic	Class 2	888.3358	2014-12-24
OQI	Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented	Orthopedic	Class 2	888.3353	2014-12-24
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2014-12-24
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2014-12-24
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2026-01-29
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2026-01-29
HTO	Reamer	Orthopedic	Class 1	888.4540	2013-01-31
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2026-01-29
HSN	Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3110	2013-12-23
HXI	Passer, Wire, Orthopedic	Orthopedic	Class 1	888.4540	2015-01-10
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2026-01-29
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2026-01-29
NKG	Posterior Cervical Screw System	Orthopedic	Class 2	888.3075	2026-01-29
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2026-01-29
GFF	Bur, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4820	2013-01-31
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2026-01-29
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2022-01-28
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2026-01-27
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2024-09-10
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2016-02-22
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2024-06-19
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2015-01-15
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2015-01-15
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2015-01-15
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2015-01-15
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2015-01-15
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2026-01-29
KRR	Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3540	2023-05-10
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2018-12-03
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2026-01-29
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2022-01-28
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2026-01-28
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2026-01-28
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2026-01-28
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2026-01-28
OSH	Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	Orthopedic	Class 2	888.3070	2026-01-28
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2026-01-28
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2013-01-31
PML	Bone Cement, Posterior Screw Augmentation	Orthopedic	Class 2	888.3027	2026-01-29
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2026-01-27
JDW	Pin, Fixation, Threaded	Orthopedic	Class 2	888.3040	2020-05-18
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2026-01-29
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2026-01-29
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2026-01-29
HSN	Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3110	2013-01-31
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Orthopedic	Class 2	888.3360	2016-04-20
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2016-04-20
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2016-04-20
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2016-04-20
KRO	Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3510	2023-03-28
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2022-01-28
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2013-01-31
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2013-12-23
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-12-23
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2022-01-28
NKG	Posterior Cervical Screw System	Orthopedic	Class 2	888.3075	2022-01-28
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2018-11-05
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2014-12-30
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2014-12-30
JDC	Prosthesis, Elbow, Constrained, Cemented	Orthopedic	Class 2	888.3150	2018-06-19
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2013-12-23
NKG	Posterior Cervical Screw System	Orthopedic	Class 2	888.3075	2026-01-29
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2026-01-29
HXC	Wrench	Orthopedic	Class 1	888.4540	2013-01-31
NBH	Accessories, Arthroscopic	Orthopedic	Class 1	888.1100	2015-11-19
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2022-01-28
OWI	Bone Fixation Cerclage, Sublaminar	Orthopedic	Class 2	888.3010	2026-01-29
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-01-28
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-01-28
MRW	System, Facet Screw Spinal Device	Unknown	Class U	N/A	2013-01-31
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2022-01-28
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2022-01-28
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2013-01-31
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-01-31
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2015-11-19
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2014-12-24
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2014-12-24
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2016-05-25
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2016-05-25
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2016-05-25
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2026-01-29
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2026-01-27
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2026-01-28
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2026-01-27
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2026-01-29
JDS	Nail, Fixation, Bone	Orthopedic	Class 2	888.3030	2026-01-29
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2026-01-29
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2026-01-29
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2026-01-29
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2013-01-31
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2013-01-07
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2013-01-07
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Neurology	Class 2	882.4310	2013-01-07
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2026-01-29
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2014-11-22
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2014-11-22
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2023-11-14
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2022-01-28
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2026-01-29
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2026-01-29
NKG	Posterior Cervical Screw System	Orthopedic	Class 2	888.3075	2026-01-29
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2026-01-29
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2026-01-27
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2026-01-28
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2015-01-15
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2024-11-01
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2026-01-29
PGN	Growing Rod System- Magnetic Actuation	Orthopedic	Class 2	888.3070	2026-01-29
HTC	Pliers, Surgical	General, Plastic Surgery	Class 1	878.4800	2018-08-17
HWB	Extractor	Orthopedic	Class 1	888.4540	2013-01-31
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2026-01-29
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2013-01-31
JDS	Nail, Fixation, Bone	Orthopedic	Class 2	888.3030	2013-12-23
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2013-12-23
HWJ	Awl	Orthopedic	Class 1	888.4540	2013-01-31
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2015-11-19
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2026-01-29
HTR	Rasp	General, Plastic Surgery	Class 1	878.4800	2013-01-31
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2026-01-29
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2015-01-07
HTZ	Instrument, Cutting, Orthopedic	General, Plastic Surgery	Class 1	878.4800	2015-01-10
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2026-01-29

Official Correspondent

Thomas Sobieck

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

NG Instruments, Inc dba Avalign Cutting Instruments

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
K012175	Encore Orthopedics, Inc.	PASS SPINAL SYSTEM	2001-07-31
K963639	Acromed Corp.	ACROMED PEDICLE SCREW	1996-11-14
K163363	Surgtech, Inc.	SurgTech Thoracolumbosacral (TLS) Posterior Fixation System	2017-04-05
K252461	Spinal Resources, Inc.	Swedge Pedicle Screw Fixation System Bezier Rod	2026-01-13
K140696	Pioneer Surgical Technology, Inc.	STREAMLINE TL SPINAL FIXATION SYSTEM	2014-04-10

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

Similar Registrations

Registration Number	Establishment Name	Location
3009941480	LISI MEDICAL REmmele	Big Lake, MN, US
3004635447	C&W SWISS, INC.	CLAYTON, OH, US
3015869493	Jabil Switzerland Manufacturing GmbH (Mezzovico)	Mezzovico Ticino, CH
3016050940	Olive Branch Distribution Center	Olive Branch, MS, US
3009417901	SYNTHES GMBH	Zuchwil Solothurn, CH

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1835251. Last updated year: 2026. Please use registration number 1835251 when referencing this establishment in official correspondence.