BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ORTHOPEDIATRICS, CORP

    Reg #: 3006460162 · FEI: 3006460162 · Expires 2026
    View on FDA
    Products
    64
    Proprietary Names
    100
    Establishment Types
    3
    Classifications
    64

    Registration Details

    Registration Name
    ORTHOPEDIATRICS, CORP
    Registration Number
    3006460162
    FEI Number
    3006460162
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    2850 Frontier Dr
    City
    Warsaw
    State
    IN
    ZIP
    46582
    Country
    US

    Regulatory Submissions

    510(k) Number
    K251362

    Owner / Operator

    Firm Name
    ORTHOPEDIATRICS, CORP
    Operator Number
    9102640
    Address
    2850 Frontier Drive, --
    City
    Warsaw
    State
    IN
    Postal Code
    46582
    Country
    US
    Correspondent
    Ray Garrison

    Products

    Device Name Product Code
    Pin, Fixation, Smooth HTY
    Bit, Surgical GFG
    Elevator, Surgical, General & Plastic Surgery GEG
    Orthopedic Stereotaxic Instrument OLO
    Bone Fixation Cerclage, Sublaminar OWI
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component KTT
    Software For Diagnosis/Treatment OSN
    Plate, Fixation, Bone HRS
    Plate, Bone, Growth Control, Pediatric, Epiphysiodesis OBT
    Screw, Fixation, Bone HWC
    Wrench HXC
    Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment KIJ
    Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis OSH
    Appliance, Fixation, Spinal Interlaminal KWP
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Thoracolumbosacral Pedicle Screw System NKB
    Orthosis, Spinal Pedicle Fixation MNI
    Washer, Bolt Nut HTN
    Bit, Drill HTW
    Pin, Fixation, Threaded JDW
    Stylet, Surgical, General & Plastic Surgery GAH
    Reamer HTO
    Rod, Fixation, Intramedullary And Accessories HSB
    Template HWT
    Fastener, Fixation, Nondegradable, Soft Tissue MBI
    Guide, Surgical, Instrument FZX
    Driver, Surgical, Pin GFC
    Kit, Surgical Instrument, Disposable KDD
    Cutter, Wire HXZ
    Tap, Bone HWX
    Tape, Measuring, Rulers And Calipers FTY
    Passer HWQ
    Hook, Bone KIK
    Device, Fixation, Proximal Femoral, Implant JDO
    Screwdriver HXX
    Instrument, Bending Or Contouring HXP
    Osteotome HWM
    Tray, Surgical, Instrument FSM
    Prosthesis, Rib Replacement MDI
    Gauge, Depth HTJ
    Hammer, Surgical FZY
    Cutter, Surgical FZT
    Impactor HWA
    Rasp HTR
    Awl HWJ
    Extractor HWB
    Staple, Fixation, Bone JDR
    Mallet HXL
    Growing Rod System PGM
    Orthosis, Limb Brace IQI
    Instrument, Compression HWN
    File HTP
    Clamp HXD
    Punch, Surgical LRY
    Retractor GAD
    Table, Surgical With Orthopedic Accessories, Manual JEB
    Medical Device Data System OUG
    Bender HXW
    Protractor HTH
    Forceps HTD
    Tamp HXG
    Probe HXB
    Chisel, Surgical, Manual FZO
    Orthopedic Manual Surgical Instrument LXH

    Proprietary Names

    PediFlex™ Flexible Nail System Drill bit Trephine Hex driver Easy out Periosteal Elevator Response Navigation Instruments Response BandLoc Spinal Fixation Orthex External Fixation System (Point and Click Software) H-Plate PediPlate O-Plate I-Plate Wrench INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Response 5.5/6 Spine System Aspire Ortho Spine System PediFrag Percutaneous Pinning Set PediLoc Fragment System General Instruments Orthex External Fixation System Stylet OrthoPediatrics PediNail Intramedullary Platform Template Pediatric Nailing Platform Tibia OrthoPediatrics ACL Reconstruction System Guide wire OrthoPediatrics® Locking Cannulated Blade Plate System 3, 3.5, 7 Bone Screws OrthoPediatrics Bone Screws SCFE Screw Bone Screw System Cortical, Cancellous and Cannulated Bone Screws 4 Bone Screws PediScrew OrthoPediatrics Wrist Fusion Plate Tendon Passer HOOK, BONE Pediatric Plating Platform Hip SCREWDRIVER Instrument, Bending or Contouring General instruments Orthex RESPONSE™ Rib and Pelvic System Drive Rail System Orthex Half Pin Ultima Half Pin Ultima HA Coated Half Pins and Wire OrthoPediatrics PediFlex Flexible Nail System Pedi-Flex Nail Response 4.5/5 Spine System PediLoc Pedi-Loc PediLoc Locking Plate System Pediatric Plating Platform Small-Mini PediNail Intramedullary Platform Rasp Awl Mallet Vilex EZ-Fix VerteGlide Spinal Growth Guidance System Dynamic Femur Fracture (DF2) Brace; PediHip Rigid Brace ; PediHip Modular Abduction Harness OrthoPediatrics Blade Plate System Locking Cannulated Blade Plate System Pediatric Nailing Platform Femur Instrument, Compression File PediFlex and Interlocking Clamp Pediatric Nailing Platform Femur PediLoc Tibia PediLoc Tibial Plate PediFoot Deformity Correction System PediPlates OrthoPediatrics PediNail Intramedullary Nailing System PediNail OrthoPediatrics PediNail Response 5.5 Spine System I-Plates Pedi-Plates O-Plates H-Plates PediFlex Playbook BENDER OrthoPediatrics Cannulated Screw System 6.5 and 7.3mm Large Fragment Cannulated Screw System OrthoPediatrics Titanium PediPlates System Response Spine System OP Response Spine System Protractor RESPONSE 5.5/6 Cannulated Screw System Tamp General Instrument PediLoc Infant Locking Proximal Femur System Proximal Femur Locking Plate System Locking Proximal Femur Plate System RESPONSE™ Spine System RESPONSE™ 5.5/6 Spine System RESPONSE™ 4.5/5 Spine System FZO - CHISEL, SURGICAL, MANUAL

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility