BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Avalign Delivery Systems Division

    Reg #: 1835444 · FEI: 3000717687 · Expires 2026
    View on FDA
    Products
    42
    Proprietary Names
    174
    Establishment Types
    1
    Classifications
    42

    Registration Details

    Registration Name
    Avalign Delivery Systems Division
    Registration Number
    1835444
    FEI Number
    3000717687
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2121 SOUTHTECH DRIVE, SUITE 600
    City
    Greenwood
    State
    IN
    ZIP
    46143
    Country
    US

    Owner / Operator

    Firm Name
    Avalign Delivery Systems Division
    Operator Number
    9026184
    Address
    2121 Southtech Drive, Suite 600
    City
    Greenwood
    State
    IN
    Postal Code
    46143
    Country
    US
    Correspondent
    Thomas Clyne

    Products

    Device Name Product Code
    Plate, Fixation, Bone HRS
    Accessories, Arthroscopic NBH
    Orthopedic Stereotaxic Instrument OLO
    Sterilization Wrap Containers, Trays, Cassettes & Other Accessories KCT
    Orthopedic Tray OJH
    Screw, Fixation, Bone HWC
    Stimulator, Nerve ETN
    Retractor, Self-Retaining, For Neurosurgery GZT
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component KTT
    Instrument, Manual, Surgical, General Use MDM
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate MEH
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous MBL
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish MAY
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
    Orthopedic Manual Surgical Instrument LXH
    Tray, Surgical, Instrument FSM
    Prosthesis, Ankle, Uncemented, Non-Constrained NTG
    Instrument, Ligature Passing And Knot Tying HCF
    Intervertebral Fusion Device With Integrated Fixation, Lumbar OVD
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Template HWT
    Appliance, Fixation, Spinal Intervertebral Body KWQ
    Posterior Cervical Screw System NKG
    Appliance, Fixation, Spinal Interlaminal KWP
    Rod, Fixation, Intramedullary And Accessories HSB
    Orthosis, Spinal Pedicle Fixation MNI
    Thoracolumbosacral Pedicle Screw System NKB
    Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis OSH
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented MBF
    Shoulder Prosthesis, Reverse Configuration PHX
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented PAO
    Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented KWT
    Fastener, Fixation, Nondegradable, Soft Tissue MBI
    Drills, Burrs, Trephines & Accessories (Simple, Powered) HBE
    Spinal Vertebral Body Replacement Device MQP
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
    Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer MBH
    Tray, Surgical LRP
    Manual Instruments Designed For Use With Non-Fusion Spinous Process Spacer Devices QLR

    Proprietary Names

    ALPS Proximal Humerus Plating System Mako Shoulder Application Malibu Navigated Anterolateral Disc Prep Instruments CrossRoads Modular Tray System TriLEAP Plating System VOLT Proximal Humerus 3.5 Plating System DePuy Synthes MatrixSTERNUM Fixation System are registered as an accessory to Plate, fixation, bone under the Product Code in 510(k) submission K221809 Avalign Delivery Systems does not manufacture Plate, fixation, bone. This listing has been made because cases and trays Steripack Instrument, Manual Surgical for General Midas Rex Attachments and Dissecting Tools for Mazor TRILEAP Plating System VOLT Mini Fragment and VOLT Small Fragment D177809 Mako Instrument Trays 3590-08 PREBENT ROD TRAY PathFinder NXT 2790-04 HARMONY SMTH & CTTNG DISTR INS Harmony Posterior 1992-01 THERMOFORMED CADDY LID Harmony 2995-01 HARMONY ANT DISCECTOMY TRAY- L Harmony Anterior 1790-24 SINGLE LEVEL CADDY LID - LEFT ANT-CER 3590-12 MANIPULATION TRAY I PathFinder NXT 9290-09 PEDESTAL SYSTEM NON-STERILE TR Pedestal 790-29 SHORT SCREW CADDIE NEX-LINK 1790-33 MULTI LEVEL 4 LEVEL CADDY ANT-CER 791-31-2 SELF-TAPPING THORACIC SCREW CA NEX-LINK 3590-09 STANDARD TRAY I PathFinder NXT 3590-07 ROD BASE PathFinder NXT 3390-17 SEQUOIA DEGEN ROD TRAY SEQUOIA 2143 LID T-LINK CADDY, TITLE 2 MINIT (TiTLE 2) 3590-45 4.5 PEDICLE SCREW CADDY PathFinder NXT 3590-16 CLASSIC TRAY PathFinder NXT 2690-8 TRAXIS MODULAR INSERT TRAY TRAXIS 3590-13 MANIPULATION TRAY II PathFinder NXT 790-27 LONG SCREW CADDIE NEX-LINK 2994-01 HARMONY ANTERIOR DISCECTOMY TR Harmony Anterior 792-18 HOOKS & OFFSET CONNECTOR CADDI NEX-LINK 2994-03 HARMONY ANTERIOR PREPARATION T Harmony Anterior 1790-25 SINGLE LEVEL CADDY ANT-CER 3290-34 34 TRIAL INSERT TRAY ARDIS 792-3 NEX-LINK CLOSURE TOP CADDIE LI NEX-LINK 2995-03 HARMONY ANT PREP & DISTRACT- L Harmony Anterior 2790-02 HARMONY STANDARD INSTRUMENTS I Harmony Posterior 3290-05 ARDIS TRIALS OUTER BASE ARDIS 3290-22 22 TRIAL INSERT TRAY ARDIS 2690-7 TRAXIS FIXED TRAY INSERT TRAXIS 2692-2 CADDY LID 1 TRAXIS 7091-04 OPEN OFFSET CONNECTOR CADDIE Nex-Link OCT 2695-03 TRAXIS MOD INSTR OUTER CASE TA TRAXIS 2994-08 NEW DISTRCTOR MODULE NO. 2 Harmony Anterior 2140 SCREW CADDY IMP TITLE 2 MINIT (TiTLE 2) 3391-12 SEQUOIA ACCESSORY BIN FINGER M SEQUOIA 02555 MINIT IMPL CASE, CADDY 1 MINIT (TiTLE 2) 3391-09 SEQUOIA CLOSURE TOP/CROSSLINK SEQUOIA 2994-06 HARMONY ANTERIOR DISTRACTOR MO Harmony Anterior 3391-13 SEQUOIA ADD TRNSV CONN CADDY SEQUOIA 3390-13 SEQUOIA DEGEN 5.5MM SCREW SEQUOIA 3390-12 SEQUOIA DEGEN 4.5MM SCREW SEQUOIA 1790-28 MULTI LEVEL 2 LEVEL CADDY ANT-CER 7091-06 CLOSURE TOP CADDIE Nex-Link OCT 1591-1 CADENCE TRIALS CADDY CADENCE 7090-02 BASE LID Nex-Link OCT 3017-02 UPPER TRAY, ACC CASE, T2 TiTLE 2 3290-26 26 TRIAL INSERT TRAY ARDIS 2994-02 HARMONY ANTERIOR DISCECTOMY TR Harmony Anterior 3590-24 TAP TRAY ACCSRY BIN MAT PathFinder NXT 7090-03 THERMOFORMED IMPLANT TRAY Nex-Link OCT 7091-03 OCCIPITAL PLATE CADDIE Nex-Link OCT 3390-10 SEQUOIA TAP TRAY SS SEQUOIA 2790-03 HARMONY INSTRUMENT INSERT Harmony Posterior 792-17 NL CRSLNK, HOOKS & OFFST CN CA NEX-LINK 3590-65 6.5 PEDICLE SCREW CADDY PathFinder NXT 790-24 CLOSURE TOP CADDIE NEX-LINK 2695-04 TRAXIS MOD INSTR OUTER CASE TA TRAXIS 790-30 NEX-LINK IMPLANT INSERT NEX-LINK 3390-07 SEQ DEGEN INSTR BASE 2-SS SEQUOIA 1790-26 SINGLE LEVEL CADDY LID - RIGHT ANT-CER 3590-10 TAP TRAY INSERT PathFinder NXT 3590-14 PATHFINDER II ACCSRY BIN MAT PathFinder NXT 2695-05 TRAXIS FXD INSTR OUTER CASE TA TRAXIS 1790-31 MULTI LEVEL 3 LEVEL CADDY ANT-CER 7090-01 BRACKETED BASE Nex-Link OCT 3390-14 SEQUOIA DEGEN 6.5MM SCREW SEQUOIA 3391-10 SEQUOIA CLOSURE TOP CADDY LID SEQUOIA 3390-15 SEQUOIA DEGEN 7.5MM SCREW SEQUOIA 1590-8 CADENCE INSERT TRAY 2 CADENCE 02557 MINIT IMPL CASE,CADY 2LID MINIT (TiTLE 2) 3590-15 MNPULTION TRAYII ACSRY BIN MAT PathFinder NXT 1095-101 METAL GENERIC BASE LID Generic 430-771 Release Laminoplasty Fixation System 1095-021 2" METAL GENERIC OUTER BASE Generic 3590-75 7.5 PEDICLE SCREW CADDY PathFinder NXT 3590-22 CLASSIC TRAY INSERT PathFinder NXT 3290-07 SHAVER INSERT TRAY ARDIS 790-29-2 SELF-TAPPING POLY SCREWS CADDI NEX-LINK 3390-11 SEQUOIA DEGEN IMPLNT BASE SEQUOIA 3390-16 SEQUOIA DEGEN 8.5MM SCREW SEQUOIA 3590-23 CLASSIC TRAY AUXILIARY BIN MAT PathFinder NXT 1790-35 MULTI-LEVEL INSTRUMENT INSERT ANT-CER 3391-14 SEQUOIA ADD TRNSV CONN CADDY L SEQUOIA 3290-30 30 TRIAL INSERT TRAY ARDIS 1790-36 MULTILEVEL TOP INSERT CADDY HO ANT-CER 790-28 SMOOTH SHANK CADDIE NEX-LINK 3391-11 SEQUOIA CROSSLINK CADDY LID SEQUOIA 790-31 NEX-LINK THORACIC INSERT TRAY NEX-LINK 7090-04 THERMOFORMED SMALL TRAY Nex-Link OCT 791-31 NEX-LINK THORACIC CADDIE NEX-LINK D202599 B067394 2995-02 HARMONY ANT DISCECTOMY TRAY- S Harmony Anterior 1790-29 MULTI LEVEL CADDY LID ANT-CER 2695-06 TRAXIS FXD INSTR OUTER CASE TA TRAXIS 02551 BASE, IMPLANT CASE, MINIT MINIT (TiTLE 2) 2691-2 CADDY TRAXIS 2790-01 HARMONY STANDARD INSTRUMENTS I Harmony Posterior 3290-06 ARDIS GENERAL OUTER BASE ARDIS 3590-55 5.5 PEDICLE SCREW CADDY PathFinder NXT 2994-07 NEW DISTRACTION TRAY NO. 4 Harmony Anterior 790-26 CROSSLINK, HOOK & OFFSET CONN NEX-LINK 3590-06 IMPLANT BASE PathFinder NXT 1590-7 CADENCE INSERT TRAY 1 CADENCE 3590-11 STANDARD TRAY II PathFinder NXT 790-27-2 LONG SELF-TAPPING POLY SCREW C NEX-LINK 2995-04 HARMONY ANT PREP & DISTRACT- S Harmony Anterior 3390-08 SEQ DEGEN INSTR INS SS-1 SEQUOIA 2142 T-LINK CADDY, TITLE 2 MINIT (TiTLE 2) 2692-3 CADDY LID 2 TRAXIS 3590-05 CLOSURE TOP CADDY PathFinder NXT 1790-27 SINGLE LEVEL INSTRUMENT INSERT ANT-CER 3390-06 SEQUOIA DEGEN INSTRU BASE SEQUOIA 6553002 Hall Sterilization Tray (for Lithium Battery Configuration) Hall Sterilization Tray PowerPro System Sterilization Case, Small and lumbar in K212524 Avalign Delivery Systems does not manufacture intervertebral fusion device with bone graft, lumbar. This listing is because Medtronic cases / trays are registered as accessories to the intervertebral fusion device with bone graft, Medtronic Reusable Instruments and Accessories Avalign Delivery Systems does not manufacture appliance, fixation, spinal intervertebral body.This listing has been made because Medtronic cases and trays are registered as an accessory to the listed devices in K141632. Avalign Delivery Systems does not manufacture posterior cervical screw system. This listing has been made because Medtronic cases and trays are registered as accessories to the posterior cervical screw system in K163375 Synthes Graphic Case & Tray System Avalign Delivery Systems does not manufacture ROD, FIXATION, INTRAMEDULLARY. This listing has been made because cases and trays are registered as an accessory to ROD, FIXATION, INTRAMEDULLARY under product code in 510k submission K201346 because Medtronic cases and trays are registered as accessories to tthoracolumbosacral pedicle screw system in K153589 Avalign Delivery Systems does not manufacture thoracolumbosacral pedicle screw system. This listing has been made Avalign Delivery Systems does not manufacture drills, burrs, and trephines. This listing has been made because Medtronic cases and trays are registered as accessories to the drills, burrs, and trephines in K182436 QUADTRAC Quadriceps Tendon Harvest Guide System Sterilization Tray T2 XVBR 1.5 SPINAL SYSTEM Avalign Delivery Systems does not manufacture thoracolumbosacral pedicle screw system. The listing has been made because Medtronic cases and trays are registered as accessories to the thoracolumbosacral pedicle screw system in K15228 430-771 Release Laminoplasty Fixation 430-777 Release Laminoplasty Fixation 430-774 Release Laminoplasty Fixation 430-776 Release Laminoplasty Fixation 430-773 Release Laminoplasty Fixation 430-775 Release Laminoplasty Fixation Medtronic DIAM™ Spinal Stabilization System Triad XLR Helix VuePoint Graft Integration CoRoent NuVasive MaXcess Leverage X-CORE XLIF PGI

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)