BEUDAMED
    FDA Registration Active 🇺🇸 United States

    NGInstruments, Inc dba Avalign Cutting Instruments

    Reg #: 1835251 · FEI: 3000205591 · Expires 2026
    View on FDA
    Products
    77
    Proprietary Names
    63
    Establishment Types
    1
    Classifications
    77

    Registration Details

    Registration Name
    NGInstruments, Inc dba Avalign Cutting Instruments
    Registration Number
    1835251
    FEI Number
    3000205591
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    4643 N State Road 15
    City
    Warsaw
    State
    IN
    ZIP
    46582
    Country
    US

    Owner / Operator

    Firm Name
    NG Instruments, Inc dba Avalign Cutting Instruments
    Operator Number
    10042855
    Address
    4643 North State Road 15
    City
    Warsaw
    State
    IN
    Postal Code
    46582
    Country
    US
    Correspondent
    Thomas Sobieck

    Products

    Device Name Product Code
    Orthosis, Spinal Pedicle Fixation MNI
    Appliance, Fixation, Spinal Interlaminal KWP
    Thoracolumbosacral Pedicle Screw System NKB
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Intervertebral Fusion Device With Integrated Fixation, Cervical OVE
    Stimulator, Electrical, Evoked Response GWF
    Orthopedic Stereotaxic Instrument OLO
    Appliance, Fixation, Spinal Intervertebral Body KWQ
    Probe HXB
    Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment KIJ
    Retractor GAD
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented OQG
    Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented OQI
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Reamer HTO
    Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer HSN
    Passer, Wire, Orthopedic HXI
    Posterior Cervical Screw System NKG
    Bur, Surgical, General & Plastic Surgery GFF
    Interventional Fluoroscopic X-Ray System OWB
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component KTT
    Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer KRR
    Rod, Fixation, Intramedullary And Accessories HSB
    Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis OSH
    Tap, Bone HWX
    Bone Cement, Posterior Screw Augmentation PML
    Pin, Fixation, Threaded JDW
    Intervertebral Fusion Device With Bone Graft, Cervical ODP
    Prosthesis, Hip, Hemi-, Femoral, Metal KWL
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate MEH
    Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
    Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer KRO
    Plate, Fixation, Bone HRS
    Screw, Fixation, Bone HWC
    Clamp HXD
    Prosthesis, Elbow, Constrained, Cemented JDC
    Wrench HXC
    Accessories, Arthroscopic NBH
    Bone Fixation Cerclage, Sublaminar OWI
    System, Facet Screw Spinal Device MRW
    Washer, Bolt Nut HTN
    Nail, Fixation, Bone JDS
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
    Drills, Burrs, Trephines & Accessories (Simple, Powered) HBE
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
    Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer MBH
    Growing Rod System- Magnetic Actuation PGN
    Pliers, Surgical HTC
    Extractor HWB
    Forceps HTD
    Awl HWJ
    Rasp HTR
    Instrument, Cutting, Orthopedic HTZ
    Orthosis, Spine, Plate, Laminoplasty, Metal NQW
    Bit, Drill HTW
    Prosthesis, Intervertebral Disc MJO
    Template HWT
    Sacroiliac Joint Fixation OUR
    Bit, Surgical GFG
    Fastener, Fixation, Nondegradable, Soft Tissue MBI
    Orthopedic Manual Surgical Instrument LXH
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive OIY
    Intervertebral Fusion Device With Integrated Fixation, Lumbar OVD
    Countersink HWW
    Screwdriver HXX
    Blade, Saw, General & Plastic Surgery, Surgical GFA
    Tape, Orthopedic HXT
    Device, Fixation, Proximal Femoral, Implant JDO
    Sterilization Wrap Containers, Trays, Cassettes & Other Accessories KCT
    Guide, Surgical, Instrument FZX
    Chisel, Bone, Surgical EML
    Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer KWZ
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish MAY
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous MBL

    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 Bit, Drill ZIMMER BIOMET NEXGEN RH KNEE TIBIAL DRILL, SHORT STEM TIBIA Spider Cervical Plating System - XSpine Typhoon Facet Screw Fixation System - Choice Spine Template 5MM CANNULATED DRILL BIT LONESTAR Cervical Stand Alone System - OrthoFix Straight Flute Reamers (6-10mm) Silex Sacroiliac Joint Fusion System - XSpine Pin Pliers Triatholon Zavation Cervical Plate System A200 Knee System Silverton Azure Anterior Cervical Plate System - OrthoFix Screwdriver Tape, Orthopedic S128 ALIF System Device, fixation, proximal femoral, DePuy AWL TIP TAP 4.35/5/6/7/8 NAV Smith and Nephew PERI-LOC Instrument, Surgical, Orthopedic AC-Powered Guide Wire Bone Remover Inbone - Wright Medical

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)