BEUDAMED
    FDA Registration Active 🇮🇳 India

    Auxein medical Private limited

    Reg #: 3010303097 · FEI: 3010303097 · Expires 2026
    View on FDA
    Products
    83
    Proprietary Names
    969
    Establishment Types
    2
    Classifications
    83

    Registration Details

    Registration Name
    Auxein medical Private limited
    Registration Number
    3010303097
    FEI Number
    3010303097
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Plot No.168,169,170 Phase-IV, Sector 57, Kundli Industrial area,, HSIIDC Sonipat- 131028, Haryana, INDIA
    City
    Sonipat Haryana
    Country
    IN

    Regulatory Submissions

    510(k) Number
    K213014

    Owner / Operator

    Firm Name
    Auxein Medical Pvt Ltd
    Operator Number
    10046810
    Address
    Plot No.168,169,170 Phase-IV, Sector 57, Kundli Industrial area, HSIIDC Sonepat- 131028, Haryana, INDIA, HSIIDC Sonipat- 131028, Haryana, INDIA
    City
    Sonipat
    State
    Haryana
    Postal Code
    131028
    Country
    IN

    US Agent

    Business Name
    510K FDA Inc.
    Contact Name
    Lee Strong
    Address
    156 E Granada Blvd
    City
    Ormond Beach
    State
    FL
    ZIP
    32176
    Country
    US
    Email
    [email protected]
    Phone
    386 8466037

    Products

    Device Name Product Code
    Plate, Fixation, Bone HRS
    Screw, Fixation, Bone HWC
    Reamer HTO
    Tap, Bone HWX
    Curette HTF
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component KTT
    Appliance, Fixation, Nail/Blade/Plate Combination, Single Component KTW
    Tray, Surgical LRP
    Starter, Bone Screw HWD
    Handle, Instrument, Dental EJB
    Mixer, Cement, For Clinical Use JDZ
    Screwdriver HXX
    Container, Specimen, Sterile FMH
    Trephine HWK
    Probe HXB
    Driver, Prosthesis HWR
    Pusher, Socket HXO
    Countersink HWW
    Hammer, Surgical FZY
    Fastener, Fixation, Nondegradable, Soft Tissue MBI
    Positioner, Socket KIL
    Goniometer, Ac-Powered KQX
    Skid, Bone HWO
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
    Punch, Femoral Neck HWP
    Twister, Wire HXS
    Wrench HXC
    Halter, Head, Traction HSS
    Handle, Scalpel GDZ
    Battery, Replacement, Rechargeable MOQ
    Awl HWJ
    Set, Hollow Mill HWL
    Cutter, Wire HXZ
    Accessories, Arthroscopic NBH
    Crimper, Pin HXQ
    Scale, Stand-On, Patient FRI
    Scissors, Orthopedic, Surgical HRR
    Bed, Rocking, Breathing Assist CCO
    Fork HXE
    File HTP
    Passer HWQ
    Template HWT
    Knife, Orthopedic HTS
    Instrument, Manual, Surgical, General Use MDM
    Osteotome HWM
    Cabinet, Table And Tray, Anesthesia BRY
    Scale, Patient FRW
    Spinal Channeling Instrument, Vertebroplasty OCJ
    Rongeur HTX
    Stripper, Surgical HRT
    Instrument, Compression HWN
    Stainer, Tissue, Automated KEY
    Elevator HTE
    Unit, Traction, Hip, Non-Powered, Non-Penetrating HSR
    Instrument, Cast Application/Removal, Manual LGG
    Nail, Fixation, Bone JDS
    Extractor HWB
    Dispenser, Cement KIH
    Instrument, Bending Or Contouring HXP
    Blade, Scalpel GES
    Impactor HWA
    Stand, Infusion FOX
    Tamp HXG
    Light, Surgical, Connector FSX
    Bit, Drill HTW
    Evacuator, Vapor, Cement Monomer JDY
    Passer, Wire, Orthopedic HXI
    Goniometer, Nonpowered KQW
    Instrument, Cast Removal, Ac-Powered LGH
    Tray, Surgical, Instrument FSM
    Dislodger, Stone, Basket, Ureteral, Metal FFL
    Block, Cutting, Ent, Sterile JXS
    Gauge, Depth HTJ
    Splint, Traction HSP
    Orthopedic Manual Surgical Instrument LXH
    Holder, Needle; Orthopedic HXK
    Trocar, Gastro-Urology FBQ
    Clamp HXD
    Dynamometer, Nonpowered HRW
    Thoracolumbosacral Pedicle Screw System NKB
    Staple Driver HXJ
    Guide, Surgical, Instrument FZX
    Corkscrew HWI

    Proprietary Names

    AV Wise-Lock Elbow System Step Drill for Cephllic Screw (Lag Screw) lnJertor for Cephalic Screw (Lag Screw) Tray for Ga-mma Nail.butruments Trocar for Distil Locking Screw T Handle with SS Chuck & Key Screw Driver for End Cap for Cephllic Screw (Lag Screw) Spanner for Driver Guide Sleeve for Distal Locking Screw Guide Sleeve for Cephalic Screw (Lag Screw) Internal Sleeve for Guide Wire 3mm Container for Ga-mma Nail Instrument Set Nail Holding Screw 3mm Guide Wire, Length 400mm Depth Gauge for Distal Locking Suew Drill Sleeve for 4mm Drill Bit Tap for Cephllic Screw (Lag Suew) Trocar for Cephllic Screw (Lag Screw) Screw Driver for Set Screw Targeting Device Inverted Gauge for Cephlllc Screw (Lag Screw) Socket Wrench, Univenal Driver for Nail Holding Screw Drill Bit 4mm :s: 350mm, Jacob Chuck One Step CoDicil Reamer 17mm CoDicil Reamer Sleeve Sliding Hammer with E:rtractor Rod Femoral Cannulated Reamer, Dia 7 mm Femoral Cannulated Reamer, Dia 10.5 mm Dia 9mm Tocar Tip Headed Reamer Dia 6mm Tocar Tip Headed Reamer Flexible Cannulated Reamer Dia 11 mm For Knee ACL System Dia 3.5mm X 100mm Cannulated Reamer Dia 7mm Trocar Tip Headed Reamer Flexible Cannulated Reamer Dia 10 mm For Knee ACL System Femoral Cannulated Reamer, Dia 7.5 mm Tibial Cannulated Reamer, Dia 8 mm Flexible Cannulated Reamer Dia 5.5 mm For Knee ACL System Femoral Cannulated Reamer, Dia 6mm Tibial Cannulated Reamer, Dia 6.5mm Tibial Cannulated Reamer, Dia 9 mm Tibial Cannulated Reamer, Dia 10 mm Flexible Cannulated Reamer Dia 11.5 mm For Knee ACL System Flexible Cannulated Reamer Dia 6 mm For Knee ACL System Dia 3.2mm X 100mm Cannulated Reamer Flexible Cannulated Reamer Dia 9 mm For Knee ACL System Tibial Cannulated Reamer, Dia 12 mm Tibial Cannulated Reamer, Dia 7mm Tibial Cannulated Reamer, Dia 11 mm Femoral Cannulated Reamer, Dia 8 mm Dia 5.5mm X 100mm Cannulated Reamer Tibial Cannulated Reamer, Dia 6mm Tibial Cannulated Reamer, Dia 10.5 mm Dia 7mm Tocar Tip Headed Reamer Flexible Cannulated Reamer Dia 8.5 mm For Knee ACL System Tibial Cannulated Reamer, Dia 9.5mm Dia 6.5mm X 100mm Cannulated Reamer Dia 8mm Trocar Tip Headed Reamer Dia 6mm Trocar Tip Headed Reamer Flexible Cannulated Reamer Dia 7.5 mm For Knee ACL System Femoral Cannulated Reamer, Dia 9 mm Dia 6mm X 100mm Cannulated Reamer Dia 3mm X 100mm Cannulated Reamer Femoral Cannulated Reamer, Dia 11 mm Flexible Cannulated Reamer Dia 12 mm For Knee ACL System Femoral Cannulated Reamer, Dia 10 mm Flexible Cannulated Reamer Dia 4.7mm For Knee ACL System Dia 8mm Tocar Tip Headed Reamer Tibial Cannulated Reamer, Dia 7.5mm Dia 5mm X 100mm Cannulated Reamer Dia 9mm Trocar Tip Headed Reamer Tibial Cannulated Reamer, Dia 11.5 mm Flexible Cannulated Reamer Dia 9.5 mm For Knee ACL System Femoral Cannulated Reamer, Dia 8.5 mm Flexible Cannulated Reamer Dia 6.5 mm For Knee ACL System Cannulated Headed Reamer, Dia 4.7mm Femoral Cannulated Reamer, Dia 12 mm Tibial Cannulated Reamer, Dia 8.5 mm Flexible Cannulated Reamer Dia 8 mm For Knee ACL System Dia 4.5mm Cannulated Headed Reamer Femoral Cannulated Reamer, Dia 11.5 mm Dia 4.5mm X 100mm Cannulated Reamer Flexible Cannulated Reamer Dia 7 mm For Knee ACL System Flexible Cannulated Reamer Dia 10.5 mm For Knee ACL System Femoral Cannulated Reamer, Dia 9.5 mm Femoral Cannulated Reamer, Dia 6.5 mm Dia 4mm X 100mm Cannulated Reamer Flexible Cannulated Reamer Dia 5 mm For Knee ACL System Tap For 4.5/5.5mm PEEK Screw-In Anchor Tap For 6.5mm PEEK Screw-In Anchor Ring Curette for Meniscal Repair Ring Curette Mini Bone Curette Curette, 25 Degree Angled Down Auxein's DHS/DCS Plate System AUXEIN MEDICAL PVT LTD Auxein Medical Pvt. Ltd. Screwdriver For Polymer Interference Screw Screwdriver For Dia 5mm & Dia 6 mm Polymer Interference Screw Screwdriver For Ti Interference Screw, T25 Star Driver 4.5/5.5mm Knotless PEEK Anchor Driver Clavicle and Scapula System Exploring Probe, 90 degree Angled, Tip Dia 1mm, Graduated, 130mm Working Length, Knurled Handle Arthroscopic Probe - Shoulder Curved Probe for Meniscal Repair Arthroscopic Probe - Knee Exploring Probe, Graduated, Curved Exploring Probe, Graduated, Straight Hammer Humerus and Ulna System Auxilock Titanium Interferece Screw AUXEIN- HRS - Plate, fixation, bone HWC - Screw, Fixation, bone AUXEIN- HRS - Plate, fixation, bone HWC - Screw, Fixation, bon 3.5 mm cortical screw, bone plate system,screw fixation system,cannulated screws,4.5 mm cortical screws 4mm Drill Chuck Key - 1:1 Multipurpose Attachment 8mm Self-Locking Drill Chuck - 1:1 Multipurpose Attachment High Torque Chuck (Max Dia. 4mm) - 5:1 Reamer Attachment Kirschner Drill Attachments (Dia 1.8 - 4mm) Oscillating Saw Blade, 70 x 24.8 x 12.5mm 4mm Drill Chuck - 1:1 Multipurpose Attachment Cleaning Basket For Trauma 8mm Drill Chuck Key - 1:1 Multipurpose Attachment Mini AO - 1:1 Quick Connect Drill Attachment Charger Container For Cleaning Basket Large AO - 1:1 Quick Connect Drill Attachment Battery Case Oscillating Saw Drill Cleaning Basket For Saw Trinkle Reamer - 3:1 Reamer Attachment Power Tool Set For Trauma Power Tool Set For Saw Large AO Reamer - 3:1 Reamer Attachment Oscillating Saw Blade, 90 x 24.8 x 19.5mm High Torque Chuck (Max Dia. 4mm) - 3:1 Reamer Attachment Zimmer / Hudson - 1:1 Quick Connect Drill Attachment AO/ Trinkle - 1:1 Quick Connect Drill Attachment Battery Channel Oscillating Saw Blade, 90 x 24.8 x 25mm DHS Reamer - 3:1 Reamer Attachment Charger Conversion Large AO Reamer - 5:1 Reamer Attachment Kirschner Drill Attachments ( Dia 0.7 - 1.6mm) Zimmer / Hudson - 3:1 Reamer Attachment Zimmer / Hudson - 5:1 Reamer Attachment Small AO - 1:1 Quick Connect Drill Attachment 4mm Self-Locking Drill Chuck - 1:1 Multipurpose Attachment 8mm Drill Chuck - 1:1 Multipurpose Attachment Power Drill for Trauma 2.4 mm Radius System Auxilock Draw Tight Suture Based Anchor Mini Micro Fracture Awl, 90 degree Micro Fracture Awl, 40 degree Dia 3.2 mm Awl Awl/ Tap For 4.5/5.5mm PEEK Screw-In Anchor Micro Fracture Awl, 0 degree Mini Micro Fracture Awl, 45 degree Dia 2.9mm Awl Awl For 4.5/5.5mm PEEK Screw-In Anchor Awl/ Tap For 6.5mm PEEK Screw-In Anchor Dia 4.1mm Awl Awl For 6.5mm PEEK Screw-In Anchor Mini Micro Fracture Awl, 25 degree Mini Micro Fracture Awl, 115 degree Mini Micro Fracture Awl, 60 degree Micro Fracture Awl, 60 degree Micro Fracture Awl, 25 degree Oval Mini Punch, Right Jaws, Straight Shaft DownBiter Dia 2.7mm, Downwards Cutting, 110mm Working Length Knot Pusher for Meniscal Repair Shark Mini Grasping Forceps, Straight Jaws, Straight Shaft Dunckbill Mini Punch Cut 1.5mm, Straight Jaws, Right curved shaft Tunnel Dilator, Cannulated, Dia 7mm Hook Knife, Reverse Cutting Rotor Dia 2.7mm, 360 Degree Rotating, 110mm Working Length Suture Retriever Oval Mini Punch, Left Jaws, Straight Shaft Dunckbill Mini Punch Cut 1.5mm, Straight Jaws, Upbiter Dia 2.4mm x 250 mm Passing Pin Alligator Mini Grasping Forceps, Straight Jaws, Straight Shaft PCL Femoral Aimer Knot Pusher with Suture Cutter for Meniscal Repair Rasp, Up Mini Scissors, Shot, Upwards Cutting Button Holder With Scale Rosen Knife, Toothed Blade Half-Round Rasp PCL Tibial Aimer With O Tip Mini Rasp, Concave Jaw UpBiter Dia 2.7mm, Upwards Cutting, 110mm Working Length Mini Grasping Forceps Mini Scissors, Upwards Cutting Blunt Nose Mini Basket Punch, Straight Jaws, Straight Shaft Side Cutter Mini Basket Punch, Left Side Cutting, 2.2mm Tunnel Dilator, Cannulated, Dia 9mm Tissue Grasper, Long Retrograde Knife, 45 Degree Angled Blade Mini Rasp, Convex Jaw ACL Tip Aimer ACL Tip C Aimer, Left Oval Mini Punch, Straight Jaws, Straight Shaft Diamond Rasp, 45 Degree for Meniscal Repair ACL Elbow Aimer Suture Pull Handle Hook Scissors, Straight, Dia 2.7mm Diamond Rasp, 90 Degree for Meniscal Repair Scalpel Knife Tunnel Dilator, Cannulated, Dia 10mm Tunnel Dilator, Cannulated, Dia 8 mm Dunckbill Mini Punch Cut 1.5mm, Straight Jaws, Straight Shaft Banana Knife Needle Pusher ACL Tip C Aimer, Right Side Cutter Mini Basket Punch, Right Side Cutting, 2.2mm Dunckbill Mini Punch Cut 1.5mm, Straight Jaws, Left Curved Shaft ACL Tip O Aimer Tunnel Dilator, Cannulated, Dia 6mm Straight Rasp Mini Knife, Curve Suture Holder With Tensioner Mini Knife With V - Knotch Rasp, Down 3mm Spoon, Angled Tip Suture Cutter/Knot Pusher With Lock, Dia 4.2mm, V-Knotch, Left Opened Switching Stick Convex Rasp Mini Punch Knot Pusher Auxilock GFS Mini, GFS II Large and GFS Ultimate 3.5 MM CORTICAL SCREWS,5.4 MM CORTICAL SCREWS,3.5 MM HIP SCRES,7.4 MM SCREW Orthopedic bone plates system Sliding base Meniscus Root Marking Hook FlyKuter Guide Bullet Mini Rongeur, Straight Tendon Stripper (Closed End), Dia 6mm Tendon Stripper (Open End), Dia 7mm Tendon Stripper (Open End), Dia 6mm Tendon Stripper (Closed End), Dia 7mm Tendon Stripper (Open End), Dia 8mm Tendon Stripper (Closed End), Dia 8mm Tissue Elevator, 15 degree Up PCL Elevator With Wire Capture Hole Tissuse Elevator, 30 degree Down Tissuse Elevator, 30 degree Up Tissue Elevator, 15 degree Down Auxein Brand Humeral Nail System Auxein Brand Elastic Nail System Auxein Brand Gamma Nail System Auxein Brand Ajax Advance Nail System Auxein Brand Expert Tibia Nail System Auxein Brand Retrograde Nail System Auxein Brand Expert Femoral Nail System Tibia and Fibula System Staple Impactor Auxilock PEEK Optima Screw In Suture Anchor, Auxilock Rotador PEEK Optima Screw In Anchor Auxilock Titanium Screw In Suture Anchor Auxilock FlyKuter Dia 9.5mm, Type-I Pin, Drill Tip, Dia 2.4mm x 355mm Dia 1.8mm X 100mm Drill Bit Dia 1.5mm X 300mm Drill Bit, Nitinol Dia 3.2mm X 200mm Drill Bit Auxilock FlyKuter Dia 8.5mm, Type-I Dia 1.5mm X 300mm Drill Bit, Stainless Steel Dia 3.2mm X 200 mm Drill Bit (For Knotless Anchor) Dia 2.4mm X 300mm Drill Bit Dia 1.8mm X 300mm Drill Bit Auxilock FlyKuter Dia 8mm, Type-I Auxilock FlyKuter Dia 7.5mm, Type-I Dia 1.8mm X 325 mm Drill Bit Dia 2.8mm X 200mm Drill Bit DIa 2.8mm X 300mm Drill Bit Dia 1.8mm X 200mm Drill Bit 8 Point Drill Guide, Long Auxilock FlyKuter Dia 11.5mm, Type-I Auxilock FlyKuter Dia 10mm, Type-I Dia 1.2mm X 100mm Drill Bit Cannulated Drill Bit with Quick Coupling End, Dia 3.5mm X Length 175mm Dia 1.2mm X 110mm Drill Bit Dia 2.8mm X 100mm Drill Bit Dia 2.4mm X 200mm Drill Bit Auxilock FlyKuter Dia 7mm, Type-I Dia 2.5mm X 200 mm Drill Bit (For Knotless Anchor) Auxilock FlyKuter Dia 12mm, Type-I Auxilock FlyKuter Dia 9mm, Type-I Auxilock FlyKuter Dia 11mm, Type-I Auxilock FlyKuter DIa 10.5mm, Type-I Auxilock FlyKuter Dia 6.5mm, Type-I Dia 2.5mm X 360mm Knotless Drill bit, Long Tray C For Graft Station Instruments Container For ACL/PCL Instrument Set Lid For Container Shoulder Arthroscopy Instrument Set Tray For Shoulder Arthroscopy Instruments Set Case For Flexible Cannulated Reamer Container For Shoulder Arthroscopy Instrument Set Tray A For ACL/PCL Instruments Tray B For ACL/PCL Instruments Tray For Flexible Cannulated Reamer Case Lid For Flexible Cannulated Reamer Case Tray D For ACL/PCL Instruments Lid For Container, ACL/PCL Instrument Set Tray C for ACL/PCL Instruments Container for Graft Station Instrument Set Lid for Container, Graft Station Instrument Set Drill Bit With Stop, 16mm Reamer Head, Dia8.5mm Round Scraper, 13mm Star Screwdriver with Quick Coupling (Long) Reducer APEX Anterior Cervical Instrument Set Plates Files Distal Aiming Arm (For Distal Holes) Long Screw Driver with T-Handle, Hex 5mm Protection Sleeve For Entry Reamer 14.5/12mm Mesh Impactor (Straight) Torque Screw Driver - 2.5mm Tip, 1.5Nm Screwdriver Sleeve Hohmann Retractor, Width 6.5mm Screw Holding Sleeve For 2.7mm Cortical Screw Bending Pin with thread for 2.4/2.7mm Wise-Lock Plates Pull Scraper Drill Bit Quick Coupling Dia1.5mm x Length 96/82mm, 2-flute Tap for Dia 4.5mm Cortical Screws, Quick Coupling Reamer Head, Dia11.5mm Flexible Reamer Shaft (AO Connection) Screw Driver, Self Retaing (for Screw Removal), 2.5mm External Fixator Compression Distraction Device Guide Sleeve For Protection Sleeve 14.3mm/3.3mm Drill Sleeve 8.1/4.4mm Guide Wire, Dia1.5 x 150mm Kirschner Wire with One Side Trocar Tip, Dia1.2mm x 150mm Drill Bit Quick Coupling Dia2.4mm x Length 10/73mm, 2-flute Outer Drill Sleeve 11/8.2mm Cannulated Awl Drill Guide for Neutral and Loaded Position, Dia3.5mm Torque Limiter, 0.8Nm, with AO quick coupling (Optional) Drill Guide For Neutral and Loaded Position, Dia4.5mm/3.2mm Self Centering drill guide, Dia2.5/3.5mm Mono-Axial Reduction Screwdriver Depth Gauge Mesh Trays Quick Coupling Silicon Handle Toque Screw Driver Handle Hohmann Retractor, Dia 16mm Hex Screwdriver Countersink, for Dia3.5/4mm Screws, Quick Coupling Insertion Handle For Expert Tibia Nail Scraper, 7mm Round Scraper, 9.5mm x 8.5mm Bending Pin for Wise-Lock Plates 1.5mm Wise-Lock Plates 2.4 Drill Bit, 12mm Reduction Forceps With Points, Serrated Tray For DHS-DCS Instrument Set DCS Angle Guide Degree 95 Universal Wrench 2mm Container Wrench, 3.2mm Universal Drill Guide, 6.5/3.2mm Trephine Poly-Axial Pedicle Screwdriver PALLAS Low Profile Anterior Cervical Cage Instrument Set Steilization Container 440mm x 210mm x 100mm Container For Hand & Foot Instrument & Implant Set Tap for Dia4.5mm Cortical Screws, Quick Coupling Double Drill Guide, Dia4.5/3.2mm Extraction Screw Dia3.5mm Handle with Mini Quick Coupling Screwdriver Shaft, T8 for 2.4mm/2.7mm Screws Forceps Hexagonal Screw Driver Shaft - 2mm Tip, Quick Coupling Drill Sleeve Insert, Dia3.5/2.5mm Self Centering double drill guide,Dia4.5/3.2mm Tap, HA 2.4 Guider For Vairable Angle Plate, Dia1.8mm Screw Tray Drill Bit Plain Shank/Jacob Chuck End Dia4.3mm x 300mm Periosteal Elevator with Silicon Handle, Curved, 6mm Raspatory, Straight Knife Cervical Bladed Cage Holder External Fixator Single Clamp-Deluxe Cervical Cage Instrument Set Retractor, 15mm Guide wire with Ball Tip Dia 2.5/3.65mm x Length 1000mm - Nitinol Depth Gauge, measuring upto 50mm Round Scraper, 11mm Locking Bolt (For Distal Aiming Bar) Instrument Case For Samll Fragment Connecting Shaft Hohmann Retractor, Dia16mm Screw Holding Forceps Extraction Screw, Dia3.5mm Trephine Dia8mm Reduction Forceps Screw tray For Small Fragment Wise Lock System Tissue Protector Drill With T-Handle Dia5.2mm (For Positioning Rod) Kirschner Wire with One Side Trocar Tip, Dia2mm x 150mm Retractor, 15.5mm Hexagonal Screw Driver with Holding Sleeve,3.5mm Tip Round Scraper, 10.5mm x 10mm Coupling Screw Long For Inserting DHS-DCS Screw Guide Wire Without Ball Tip Dia2.5mm x Length 1000mm -Nitinol Drill guide 2mm Set Screw Holder (Long) Screw Measuring Gauge, Length upto 90mm Tap, 6.5mm Rod Bender, Left Bending Pin with Thread for 2mm Wise-Lock Plates Allen Key 3mm Self Centering Bone Holding Forcep, Speed Lock, 190mm Radiographic Ruler for Expert Tibia Nail Universal Drill Guide 2.4/1.8mm Trial, 9mm Star screw Driver Shaft, T8 In-Situ Bender (L) Reduction Forcep, Serrated, Speed Lock, 240mm Direct Measuring Device, Length upto 120mm 4.5mm Bending Template Torque Screw Driver Handle Hexagonal Screw Driver Shaft - 3.5mm Tip Long , Quick Coupling Trial, 7mm Marker Inserter Measuring Plate (Black) Wise-Lock Drill Sleeve 2.7mm, for Drill Bits Dia 2mm Vertaux - Occipital Instrument Set Screwdriver Hexagonal Screw Driver Shaft- 3.5mm Tip, Quick Coupling Reamer Head, Dia9.5mm Distal Aiming Device For Expert Tibia Nail Drill Bit Plain Shank/Jacob Chuck End Dia4mm x Length 300mm Threaded Drill Guide, Dia2.7mm for drill bit 2mm Protection Sleeve 11/8.6mm (For Dia4.8mm Locking Bolt) Power Gripper Implant Inserter (Short) Drill Bit Quick Coupling,Dia2mm x 110mm Connecting Rod - Impactor Proximal Aiming Device Periosteal Elevator with Silicon Handle Curved, 6mm Driver For Nail Holding Bolt Guide Wire, Dia3.2mm x Length 480mm Pointed Drill Guide with sleeve 4.5mm Root Retractor (Small) Flat Drill with T-Handle Dia5.2mm (For Positioning Rod) Steilization Container 520mm x 250mm x 100mm Compressor Countersink for 1.5mm Screw Torque Screw Driver - 3.5mm Tip, 4Nm Screwdriver Shaft, T4 For 1.5mm Screws Reamer Head, Dia11mm Entry Reamer 14.3mm/3.3mm Stylet Dia2.5mm Depth Gauge, Measuring range upto 100mm Round Scraper, 7.5mm x 6.5mm Screw Holding Sleeve For 2.4mm Cortical Screw OSTEOBONE Multiaxial Pedicle Screw Driver Bending Pin with Thread 2.4/2.7mm Wise-Lock Plates HSS Drill Bit Dia2.5, Metal Bone Impator Raspatory, Curved Rod Pusher Distal Screw Device (Static/ Dynamic Locking) Depth Gauge, Upto 60mm Double Drill Guide, Dia1.8/2.4 Trial Case Implant Inserter (Long) Drill Guide (2.4 Drill Bit) Dual Drilling Guide Stopper (For Dia4mm Drill Bit) Torque Screw Driver, 2mm, 0.8Nm "Star Drive" Long Coupling Screw For DHS DCS Screw Removal Self Centering Bone Holding Forcep Speed Lock Drill Bit Quick Coupling Dia1.8mm x Length 110/82mm, 2-flute Rod Forceps, Large Push Scraper Template 450mm OSTEOBONE Multiaxial Instrument Set Slipping Hammer Trial, 10mm x 22mm Retractor, 8mm Instrument Case For DHS DCS System Trimming Rasp Multifunctional Holder Rod Bender Forcep Guide wire without Ball Tip Dia 2.5 x Length 1000mm - Nitinol Counter Torque Screw Holding Sleeve for 1.5mm Locking Screws Compression Device For Expert Tibia Nail Drill Bit Quick Coupling, Dia3.2mm x 145mm Reamer Head, Dia13.5mm Hex Rod Rotation Forceps Allen Key for Dill Bit Stopper Dia3mm Radiographic Ruler Periosteal Elevator, Flat Pedicle Screw Measuring (White) Tap, for Cancellous Screws ,Dia6.5mm Screwdriver Star Head Sterlization Container HAND & FOOT INSTRUMENT Quick Coupling Shaft Drill Bit Quick Coupling,Dia2.5mm x 112mm Drill Bit Quick Coupling Dia1.1mm x Length 75/61mm, 2-flute Universal Drill Guide 2.7/2mm Self Centering double drill guide, Dia4.5/3.2mm Impactor Depth Gauge, measuring range upto 60mm Extraction Screw, Dia5mm Entry Cutter For Expert Tibia Nail Dia 12mm Hammer Guide Shaft Reamer Head, Dia10.5mm Tap, 7mm DHS-DCS Centering Sleeve, Short Countersink, for Dia4.5/6.5mm Screws Compactor, 18mm Drill Sleeve,Dia5.2mm (For Positioning Rod) Quick Coulping Shaft Reduction Rod Marker, Right Caliper Fixation Pin Torque Limiter Handle, 10Nm Drill Sleeve 8.5/3.3mm (For Dia3.2mm Drill Bit) Tap, 5.5mm Screw Driver, Hex 3.5mm Bone Tap Quick Coupling for Wise Lock Screws, Dia2.7mm Large Bending Iron Pair Drill Bit With Stop, 12mm Nut For Hammer Guide Shaft Implant Case Countersink For 2/2.4/2.7mm Screws Drill Bit Plain Shank/ Jacob Chuck End Dia5.2mm x Length 250mm (For Positioning Rod) DHS-DCS Direct Measuring Device 2mm Wire Sleeve Periosteal Elevator Curved Trays For Expert Tibia Nailing System Screwdriver 2mm Guide Wire Holder Screw Tray For Small fragment Screws 1.5mm Container Rod Cutter Forcep External Fixator Double Pin Clamp T- Handle For Entry Reamer DCS Tripple Reamer Drill Bit, 2.2mm Drill Bit Quick Coupling Dia1.5mm x Length 65/50mm, 2-flute Drill Bit Plain Shank/Jacob Chuck End Dia5.2mm x Length 250mm (For Positioning Rod) Bone Tap Quick Coupling for Cortical Screws, Dia3.5mm Flexible Hexagonal Screwdriver SW3 Hohmann Retractor, Dia 44mm Trial Holder Protection Sleeve 17.2/14.4mm Trial, 8mm Mesh Instrument Set Torque limited Screwdriver, 0.8N.M Mesh Forceps Guide Shaft For Coupling Screw- Long 2.4 Drill Bit, 14mm Hohmann Retractor, Dia44mm Hexagonal Screw Driver Shaft - 2.5mm Tip, Quick Coupling Bone Filler Device Plunger Measure, 18-20mm Distractor Guide Wire With Threaded Trocar Tip Dia1.5mm x Length 150mm x Thread Length 5mm Periosteal Elevator, Curved, Dia16mm Depth Gauge, measuring upto 30mm Drill Bit With Stop, 14mm Drill Bit Plain Shank/Jacob Chuck End Dia3.2mm x Length 250 (For Dia4.8mm Locking Bolt) Compression Bolt Dia4mm Threaded Drill Guide 5, for Drill Bit Dia4.3mm Multiaxial Screwdriver Round Scraper, 8.5mm x 7.5mm Screwdriver Shaft, T6, for 2mm Screws Reamer Head, Dia12.5mm Screw Holding Sleeve for 2mm Cortical Screws Double Drill Guide, Dia6.5/3.2mm External Fixator Twin Adjustable Clamp Straight Hexagonal Screw Driver with Holding Sleeve, 3.5mm Tip Drill Bit Quick Coupling Dia2mm x Length 67/55mm, 2-flute Trocar Dia4.3mm Reamer Head, Dia9mm Sliding Hammer Cleaning Pin Torque Limiter, 0.4Nm, with AO quick coupling (Optional) Sleeve Round Scraper, 9mm Bone Filler Device Outer Sheath Articulated Tension Device Key Mesh Impactor (Angled) Insert Drill Sleeve, Dia4.5/3.2mm Straight Serrated Cup Curette (Long) Periosteal Elevator Curved, 8mm Screw Holding Sleeve For 2.4mm Wise-lock Screw Screw Driver, Self Retaing (for Screw Removal), 3.5mm Holding Sleeve for 2.4/2.7mm Locking Screws Cervical Plate and Screw Box Cannulated Awl For Expert Tibia Nail Double Periosteal Elevator, Flat Universal Screw Driver, Hex 6.5mm, Ball Tip (For Nail Holding Bolt) Countersink, for Dia 4.5/6.5mm Screws Countertorque Rod Pusher 3.5mm Bending Template Mono Drilling Guide Slap Plate Container Periosteal Elevator, Round Distal Bolt, Hex-5mm (For Distal Targeting Device) Graft Impacter Sharp Hook Drill Guide for Neutral and Loaded Position, LC-DCP Dia2.5mm Bone Graft Holder Inserter for Fixation Pin Trial, 6mm Curve Tamp External Fixator Self Holding Clamp Awl Drill Sleeve Dia8.1/2.5mm Guide Wire with Threaded Tip, Dia2mm x Length 150mm x 8mm Thread Length Bone Tap Quick Coupling, Cancellous Screws, 6.5mm Positioning Rod For Expert Tibia Nail Reduction Forceps With Points, Large Screw Driver with T-Handle, Hex 3.5mm Cutting Plier (for pins and plates) Articulated Tension Device Cannulated Step Drill Bit With Stopper (For Anti-Rotation Screw) Dia6.5/2.5mm Drill Guide for Neutral and Loaded Position, DCP Dia4.5mm/3.2mm Pulling drill bit 4mm Double Drill Guide, Dia1.8/Dia2.4 Screw Holding Sleeve For 2.4 Wise-lock Screw Guide Wire with Threaded Tip Dia 3.2mm x Thread Length 12mm x 300mm Outer Drill Sleeve 10/8.1mm (For Distal Targeting Device) Guide Wire with Threaded Trocar Tip, Dia2mm x Length 150mm x 8mm Thread Length Guide Wire, Dia2.5mm x Length 340mm External Fixator Small Connecting Clamp 4 X 4 mm Modified Round Scraper, 15mm Guide Wire With Ball Tip Dia2.5/3.65mm x Length 1000mm -Nitinol Curved Curettes, Right Poly-Axial Reduction Screwdriver Hexagonal Screw Driver with Holding Sleeve - 2.5mm Tip 2.7mm Contaitner Trocar Dia2.5mm Screw Hoding Forcep Depth Gauge, Length upto 100mm External Fixator Twin adjustable Clamp Curved T Handle, Quick coupling Ratchet Handle Steilization Container 520mm x 250mm x 130mm Reduction Forcep, Serrated Jaws, Speed Lock, 160mm Impactor, Round Mono-Axial Pedicle Screwdriver Hohmann Retractor, 8.5mm 2.4 Drill Bit, 16mm Drill Guide, Dia2.5/3.5mm 3mm Drill Bit Tap, 4.5mm Hexagonal Screw Driver with Holding Sleeve- 2mm Tip Hohmann Retractor, 15.5mm Position Rod Distal Targeting Device Stopper (For Dia3.2mm Drill Bit) Kirschner Wire with Trocar Tip Both End Dia2.5mm x 250mm Double Drill Guide, Dia2/2.7 Osteotome Double Periosteal Elevator, Round Torque limited Screwdriver, 0.8Nm Trial, 14mm x 22mm Insert For Distractor Pin DHS Angle Guide Degree 130 Curved Awl Stabilizing Device (For Positioning Rod) Graft Impactor Cutting Forceps Rod Holder Curved Bending Template Retractor, 6mm Trial, 10mm Tap, HA 2.7 Countersink for Dia2/2.4/2.7mm Screws Double Drill Guide, 6/8 Guide Wire with Threaded Trocar Tip, Dia1.2mm x Length 230mm x 10mm Thread Length Trocar For Protection Sleeve Dia8mm Bending Iron Pair Elevator Positioning Rod 8.1/5.2mm Curettes, Straight T-Handle with Quick Coupling Drill Bit Quick Coupling,Dia4.5mm x 145mm 9mm Plate Hook Forceps Impactor, Flat Block For Connecting Shaft Guide For Cage Locking Device Bone Tap Quick Coupling, Cortical Screws, 4.5mm Awl, 2mm Bending Pliers Threaded Drill Guide, Dia3.5mm for drill bit 2.8mm Screw Driver with T-Handle, Hex 3.5mm (For Dia4.8mm Locking Bolt) In-Situ Bender (R) Tap 3mm Large Bending Template Depth Gauge, measuring range upto,100mm Locking Cap Pusher Threaded Guide Wire, Dia2.5mm x Thread Length 10mm x Length 340mm Trial, 11mm Rod Push Forceps Proximal Aiming Device (For Dia4.4mm Locking Bolt) Guide Wire With Threaded Tip, Dia1.2 x 150 x 5mm Thread Length DHS Tripple Reamer Template 120mm Laminectomy Punches External Fixator Transverse Clamp Drill Sleeve 8/4mm (For Dia4mm Drill Bit) Distal Aiming Bar Drill Bit Quick Coupling Dia2.7mm x Length 102mm, 2-flute Drill Guide,Dia2/2.7mm Slap Hammer Guide Sleeve for Dia1.2mm K. Wires Screw Holding Sleeve For 2.7 Cortical Screw Reamer Head, Dia 7.5,mm Drill Bit Quick Coupling,Dia3.5mm x 112mm Screwdriver Shaft "Star Drive" Screw Holding Sleeve For 2.4 Cortical Screw Aura Cage (TLIF) Instrument Set Inserter for Position Rod Depth Gauge, Length upto 90mm (For Dia4.8mm Locking Bolt) Screw holding sleeve Hexagonal Screw Driver with Holding Sleeve-2.5mm Tip Straight Serrated Cup Curette (Short) Drill Bit Quick Coupling with Stopper, Dia 4.3mm x Length 225mm Allen Key, Hex 5mm Hook Probe Universal Drill Guide 2/1.5mm Screw Driver Holding Sleeve Screw Driver Shaft,T8, For 2.4mm/2.7mm Screws Trial, 10mm x 26mm Strar Head Screwdriver Shaft,T8 Trial, 8mm x 22mm Reamer Head, Dia13mm Mesh Tray Reamer Head, Dia10mm Tap, 6mm DHS-DCS lmpactorType-1 Star Screw Driver For 2.4/2.7mm Screws External Fixator Small Single Clamp 4 X 2.5 mm Modified Periosteal Elevator, Curved,16mm Probe Measure, 22-25mm DHS-DCS Tap For DHS Instrument Set Screw Tray for Large Fragment Guide Wire with Threaded Tip, Dia 2mm x Length 230mm x 10mm Thread Length External Fixator Open Single Pin Clamp Drill Sleeve 8/5.3mm (For Positioning Rod) Bolt For Proximal Aiming Device Torque Screw Driver - 2mm Tip, 0.8Nm Holding Sleeve for 2.4mm Cortical Screws External Fixator Tube to Tube Clamp Screw Holding Sleeve for 2mm Locking Screws 2.4 Adjustable Drill Bit Bone Plugger Hex Rod Rotation Wrench Trial, 12mm x 22mm Entry Reamer Dia 12mm Drill Bit, Dia2 x 140mm Impactor - Extractor Rod Cervical Distractor Nail Holding Bolt Reamer Head, Dia14mm Combination Wrench 11mm External Fixator Connecting Clamp Breaker 3.5mm Cortical Tap Bolt For Distal Aiming Arm DHS-DCS Centering Sleeve, Long 4mm Tap Drill Bit Quick Coupling with Stopper, Dia2.8mm x Length 165mm Periosteal Elevator, Curved, 8mm VERTAUX - 5.5 Pedicle Screw Instrument Set Handle With Quick Coupling Wise-Lock Drill Sleeve 2mm, for Drill Bit, Dia1.5mm Protection Drill Sleeve 10/8.1mm Marker (R) Trial, 4mm Pedicle Curved Probe Quick Coupling Handle Inserion Handle Star Screw Driver For 1.5mm Screws T-handle Mesh Cutter T-Handle with Quick Coupling For Entry Reamer Drill Sleeve, Dia1.8/2.4 Screwdriver, Sw 3 T-Handle with Quick Coupling For DHS-DCS System Marker (L) Wise-Lock Drill Sleeve 1.5mm, for Drill Bit, Dia1.1mm HSS Drill Bit, Metal, Dia3.5mm Compactor, 12mm Stopper For Drill Bit Dia4.3mm Instrument Trays Holding Sleeve 2.4/2.7mm Locking Screws Hohmann Retractor, Width15.5mm Root Retractor (Large) Marker, Left Reduction Forceps With Points, Small Star Screw Driver For 2mm Screws Handle With Quick Coupling (Straight) Round Scraper, 7mm Plate Holder Drill Bit, Dia2.7 x 140mm Trial, 5mm Self Centering Bone Holding Forcep Reamer Head, Dia12mm Reduction Forceps, Serrated, Speed Lock, 210mm Trochar Dia3.2mm Allen Key, Hex 3mm Bone Tap, Quick Coupling for Cancellous Screws, Dia4mm Measure, 10-12mm DHS-DCS lmpactorType-11 Curved Curettes, Left Drill Bit Quick Coupling Dia2mm x Length 110mm, 2-flute Guide Wire With Threaded Trocar Tip Dia2.5mm x 250mm x 10mm Thread Length Hohmann Retractor, 6.5mm Scraper, 8mm Guide Wire, Dia1.2 x 150mm Pedicle Straight Probe Insert Drill Sleeve, Dia 4.5/3.2mm Drill Bit Quick Coupling, Dia4.5mm x 145mm Drill Bit, Dia2.4 x 140mm Holding Sleeve 2.7mm for Cortical Screws Screw Holder, Sw 3 Proximal Aiming Device (For Dia4.8mm Locking Bolt) Allen Wrench, Hex 5mm Scraper, 9mm Screw Holding Forceps, Guide Wire, with threaded Trocar Tip, Dia1.2mm x Length 150mm x 5mm Thread Length Curved Trial Pusher Screw Holding Sleeve for 1.5mm Cortical Screws Reduction Forcep, Pointed, Ratchet Lock, 240mm Drill Bit Quick Coupling, Dia2mm x 100mm Measure, 14-16mm Double Drill Guide,Dia4.5/3.2mm Nail Holding Bolt For Expert Tibia Nail Reduction Device Trail, 6mm x 24mm Compactor, 6mm Guide Sleeve for Dia 2mm K. Wires Drill Guide for Neutral and Loaded Position, LC-DCP Dia3.2mm Curettes, Ring Retractor, 10mm Guide Wire with Threaded Trocar Tip, Dia1.5mm x Length 150mm x 5mm Thread Length Depth Gauge, measuring range upto,110mm DHS Angle Guide Degree 135 Proximal Aiming Bar Tray Reduction Forceps, Pointed, Small Trial, 12mm x 26mm Threaded Inserter Trocar for Sleeves 8mm (For Distal Targeting Device) Torque Limiter with Quick coupling, 1.2Nm Reduction Forceps, Pointed, Ratchet Lock, 210mm Hexagonal Screw Driver Shaft - 3.5mm Tip, Quick Coupling, short Double Drill Guide, 10/12 Bending Forceps Reamer Head, Dia 8mm Plate Bender Locking Bolt For Proximal Aiming Bar Implant Support Crosslink Hooks Holder 2.4mm Container Kirschner Wire with One Side Trocar Tip, Dia1.5mm x 150mm Intervertebral Disc(IVD) Rongeurs, Straight Depth Gauge, measuring range upto 50mm, for 2.4mm/2.7mm Screws Reduction Forceps, Serrated Jaws Stright probe Reduction Forcep, Pointed, Ratchet Lock, 180mm Trial, 14mm x 26mm Depth Gauge (With Protector) Tap, for Cancellous Screws, Dia6.5mm Lumbar Cage Intrument Set 3mm Template Intervertebral Disc (IVD) Rongeurs, Curved Quick Coupling Handle, Straight Drill Guide for Neutral and Loaded Position, DCP Dia2.5mm Double Drill Guide 1.5/1.1mm Rod Bender Sleeve With Handle Straight Awl Rod Bender, Right Bolt For Distal Aiming Device 3mm Rod Holding Forceps Universal Drill Guide, 4.5/3.2mm Retractor, 6.5mm Wise-Lock Drill Sleeve 2.4mm, for Drill Bit Dia1.8mm Drill Bit, Dia1.8 x 140mm Trial, 8mm x 26mm DHS-DCS Wrench Hexagonal Screwdriver SW2 Hexagonal Screw Driver Shaft - 3.5mm Tip, Quick Coupling Container For Expert Tibia Nailing System Smilie Miniscotome, 7mm Wide, Straight Cutting Edge Tunnel Plug, 7-8mm Pin, Trocar-Tip, Dia 2.4mm x 355mm Graft Sizer, 6mm to 9mm (1mm Steps) Tunnel Plug, 9-10mm Depth Gauge For Knee ACL/PCL Instrument Dia 1.2mm X 150mm Threaded Guide wire Screwdriver Shaft For Polymer Interference Screw, Hudson Coupling Trocar Tip Obturator - Curve Probe Hook, Graduated, 1mm Hook, Dia 2.3mm, 140mm Working Length Dia 4.5 Spade drill Pin Hook Probe and Retractor, 40mm Working Length, 3mm Hook Length - 45 Degree Smilie Miniscotome, 3mm Wide, Straight Cutting Edge Tunnel Plug, 8-9mm Graft Sizer, 6mm to 12mm (0.5mm steps) PCL Curved Curette Graft Station Board Smart Hook Suture passer, Right Ratchet Handle For Hudson Coupling Screwdriver Shaft Tunnel Notcher Dia 2.4mm Passing Pin PCL Straight Currete, Closed End PCL Suture Pusher Smart Hook Suture passer, Straight Hook Probe and Retractor, 40mm Working Length, 2mm Hook Length - 90 Degree Dia1.2mm X 180mm Blunt tip Guide wire Screwdriver Shaft For Titanium Interference Screw, T25 Star Driver, Hudson Coupling Graft Sizer, 4mm to 7mm (0.5mm Steps) Trocar Tip Obturator Needle With Lateral Opening For ESCORPIAN Suture Passer ESCORPIAN Suture Passer PCL Rasp, Curved Trocar Tip Obturator, Long Probe Hook, Graduated, 1mm Hook, Dia 1.5mm, 75mm Working Length Nitinol Guide Wire Dia 1.2mm x Length 300mm (For Interference Screws) RetroConstruction Drill Guide Handle, Side Release Quick Coupling T-Handle For Tunnel Dilator Dia1.5mm K-Wire Drill Guide Bullet Passing Pin, Dia 2.4mm x 250mm Smilie Miniscotome, 5mm Wide, Straight Cutting Edge Auxein Nailing System, Sterile Graft Grasper Clamp - Left Graft Grasper Clamp - Right Auxein Brand Vertaux 5.5 mm Pedicle Screw System 8 Point Slotted Drill Guide, Length 50mm Femoral ACL Guide, Left Single Lumen Cannula for Meniscal Repair, 10 Degree Curve Transportal Femoral Offset Guide, 6mm Femoral ACL Guide, Right 8 Point Drill Guide, Length 100mm PCL Tibial Guide with C Tip Transtibial Femoral Offset Guide, 7mm Transtibial Femoral Offset Guide, 5mm Slotted Cannula Transportal Femoral Offset Guide 5mm 8 Point Slotted Drill Guide, Length 190mm Single Lumen Cannula for Meniscal Repair, 40 Degree Curve V-Mouth Drill Guide - Curve PCL Femoral Guide Transportal Femoral Offset Guide, 7mm Transtibial Femoral Offset Guide, 6mm Single Lumen Cannula for Meniscal Repair, 20 Degree Curve Single Lumen Cannula for Meniscal Repair, Straight Bender for Cannula Guide Pin Sleeve Drill Sleeve For FlyKuter Single Lumen Cannula for Meniscal Repair, 30 Degree Curve Tibial ACL Marking Hook 8 Point Drill Guide PCL Tibial Guide with O Tip Drill Guide Handle V-Mouth Drill Guide

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device