FDA Registration Active 🇮🇳 India

Bone Plugger

Reg #: 3010303097 · FEI: 3010303097 · Expires 2025
Products
1
Proprietary Names
633
Establishment Types
2
Classifications
1

Registration Details

Registration Name
Auxein medical Private limited
Registration Number
3010303097
FEI Number
3010303097
Status
Active
Expiry Year
2025
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

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
Phone
386 8466037

Products

Device Name Product Code
Orthopedic Manual Surgical Instrument LXH

Proprietary Names

Bone Plugger Extraction Screw, Dia3.5mm Drill Bit Quick Coupling,Dia2mm x 110mm Tissue Protector Guide Wire, Dia3.2mm x Length 480mm Entry Reamer Dia 12mm Drill Bit, Dia2 x 140mm Cervical Distractor Nail Holding Bolt Hexagonal Screw Driver with Holding Sleeve,3.5mm Tip Combination Wrench 11mm Round Scraper, 10.5mm x 10mm Drill guide 2mm Screw Holding Sleeve For 2.4mm Cortical Screw Bolt For Distal Aiming Arm T- Handle For Entry Reamer Wise-Lock Drill Sleeve 2.7mm, for Drill Bits Dia 2mm Drill Bit, 2.2mm Distal Aiming Device For Expert Tibia Nail Hex Rod Rotation Wrench Proximal Aiming Device Trial, 12mm x 22mm Impactor - Extractor Rod Trial Holder Flat Drill with T-Handle Dia5.2mm (For Positioning Rod) Trial, 8mm Torque Screw Driver - 3.5mm Tip, 4Nm Reamer Head, Dia11mm Breaker Stylet Dia2.5mm Round Scraper, 7.5mm x 6.5mm 3.5mm Cortical Tap DHS-DCS Centering Sleeve, Long Universal Drill Guide, 6.5/3.2mm Star Screw Driver For 2mm Screws PALLAS Low Profile Anterior Cervical Cage Instrument Set External Fixator Twin Adjustable Clamp Straight Drill Bit Quick Coupling Dia2mm x Length 67/55mm, 2-flute Drill Bit, Dia2.7 x 140mm Sliding Hammer Self Centering Bone Holding Forcep Extraction Screw Dia3.5mm Cleaning Pin Trochar Dia3.2mm Forceps Sleeve Measure, 10-12mm Bone Filler Device Outer Sheath Articulated Tension Device Key Straight Serrated Cup Curette (Long) Drill Bit Quick Coupling Dia2mm x Length 110mm, 2-flute 2.4 Adjustable Drill Bit Screw Holding Forceps Awl, 2mm Trephine Dia8mm Reduction Forceps Drill With T-Handle Dia5.2mm (For Positioning Rod) Screw Driver with T-Handle, Hex 3.5mm (For Dia4.8mm Locking Bolt) Retractor, 15.5mm Tap 3mm Reamer Head, Dia14mm Locking Cap Pusher External Fixator Connecting Clamp Coupling Screw Long For Inserting DHS-DCS Screw Set Screw Holder (Long) Rod Push Forceps Tap, 6.5mm Guide Wire With Threaded Tip, Dia1.2 x 150 x 5mm Thread Length Raspatory, Curved Intervertebral Disc(IVD) Rongeurs, Straight Periosteal Elevator, Flat Reduction Forceps, Serrated Jaws Tap, for Cancellous Screws ,Dia6.5mm Screwdriver Star Head Implant Inserter (Long) Sterlization Container HAND & FOOT INSTRUMENT Drill Guide (2.4 Drill Bit) Stopper (For Dia4mm Drill Bit) Self Centering double drill guide, Dia4.5/3.2mm Quick Coupling Handle, Straight Depth Gauge, measuring range upto 60mm Rod Forceps, Large Rod Bender, Left Push Scraper T Handle, Quick coupling Ratchet Handle Reduction Forcep, Serrated Jaws, Speed Lock, 160mm Trial, 10mm x 22mm Hohmann Retractor, 8.5mm Instrument Case For DHS DCS System Reduction Forcep, Serrated, Speed Lock, 240mm Multifunctional Holder Torque Screw Driver Handle 3mm Drill Bit Hexagonal Screw Driver with Holding Sleeve- 2mm Tip Screw Holding Sleeve for 1.5mm Locking Screws Distal Targeting Device Drill Bit Quick Coupling, Dia3.2mm x 145mm Inserter for Position Rod Screw holding sleeve Quick Coupling Silicon Handle Drill Bit Quick Coupling with Stopper, Dia 4.3mm x Length 225mm Hohmann Retractor, Dia 16mm Nail Holding Bolt For Expert Tibia Nail Allen Key, Hex 5mm Insertion Handle For Expert Tibia Nail Compactor, 6mm Universal Drill Guide 2/1.5mm Bending Pin for Wise-Lock Plates 1.5mm Wise-Lock Plates Screw Driver Shaft,T8, For 2.4mm/2.7mm Screws Trial, 10mm x 26mm Reamer Head, Dia13mm Tray For DHS-DCS Instrument Set Reamer Head, Dia10mm Universal Wrench Rod Bender Straight Awl Inserter for Fixation Pin 3mm Rod Holding Forceps Awl Drill Bit Quick Coupling, Dia4.5mm x 145mm Positioning Rod For Expert Tibia Nail Screw Holder, Sw 3 Wise-Lock Drill Sleeve 2.4mm, for Drill Bit Dia1.8mm Trial, 8mm x 26mm Double Drill Guide, Dia1.8/Dia2.4 Hexagonal Screw Driver Shaft - 3.5mm Tip, Quick Coupling Guide Wire with Threaded Trocar Tip, Dia2mm x Length 150mm x 8mm Thread Length Guide Wire, with threaded Trocar Tip, Dia1.2mm x Length 150mm x 5mm Thread Length Container For Expert Tibia Nailing System Guide Wire With Ball Tip Dia2.5/3.65mm x Length 1000mm -Nitinol External Fixator Double Pin Clamp Measuring Plate (Black) Screwdriver Drill Bit Plain Shank/Jacob Chuck End Dia5.2mm x Length 250mm (For Positioning Rod) Drill Sleeve 8.1/4.4mm Flexible Hexagonal Screwdriver SW3 Pointed Drill Guide with sleeve 4.5mm Drill Bit Quick Coupling Dia2.4mm x Length 10/73mm, 2-flute Hohmann Retractor, Dia 44mm Root Retractor (Small) Countersink for 1.5mm Screw Torque limited Screwdriver, 0.8N.M Self Centering drill guide, Dia2.5/3.5mm Guide Shaft For Coupling Screw- Long OSTEOBONE Multiaxial Pedicle Screw Driver Bone Graft Holder Reamer Head, Dia11.5mm DCS Tripple Reamer External Fixator Self Holding Clamp Flexible Reamer Shaft (AO Connection) Screw Driver, Self Retaing (for Screw Removal), 2.5mm Drill Bit Quick Coupling Dia1.5mm x Length 65/50mm, 2-flute Guide Sleeve For Protection Sleeve 14.3mm/3.3mm Bone Tap Quick Coupling for Cortical Screws, Dia3.5mm Kirschner Wire with One Side Trocar Tip, Dia1.2mm x 150mm Cannulated Awl Protection Sleeve 17.2/14.4mm Guide Wire with Threaded Tip Dia 3.2mm x Thread Length 12mm x 300mm Torque Limiter, 0.8Nm, with AO quick coupling (Optional) Mesh Instrument Set Drill Guide For Neutral and Loaded Position, Dia4.5mm/3.2mm Mesh Forceps Proximal Aiming Bar Drill Bit With Stop, 16mm Extraction Screw, Dia5mm Hammer Guide Shaft APEX Anterior Cervical Instrument Set Torque Limiter with Quick coupling, 1.2Nm Distal Aiming Arm (For Distal Holes) Drill Sleeve,Dia5.2mm (For Positioning Rod) Hexagonal Screw Driver Shaft - 3.5mm Tip, Quick Coupling, short Long Screw Driver with T-Handle, Hex 5mm Protection Sleeve For Entry Reamer 14.5/12mm Reduction Rod Torque Screw Driver - 2.5mm Tip, 1.5Nm Caliper Screw Holding Sleeve For 2.7mm Cortical Screw Drill Bit Quick Coupling Dia1.5mm x Length 96/82mm, 2-flute Tap, 5.5mm Curve Tamp Slipping Hammer Bone Tap Quick Coupling, Cancellous Screws, 6.5mm Implant Case Retractor, 8mm Reduction Forceps With Points, Large Articulated Tension Device Drill Bit Plain Shank/ Jacob Chuck End Dia5.2mm x Length 250mm (For Positioning Rod) Pulling drill bit 4mm 2mm Wire Sleeve External Fixator Small Connecting Clamp 4 X 4 mm Modified 2.7mm Contaitner Guide Wire Holder Compression Device For Expert Tibia Nail Screw Hoding Forcep 1.5mm Container Sharp Hook Screw Driver, Hex 3.5mm Bone Tap Quick Coupling for Wise Lock Screws, Dia2.7mm T-Handle with Quick Coupling For Entry Reamer Large Bending Iron Pair Drill Bit With Stop, 12mm Drill Sleeve, Dia1.8/2.4 T-Handle with Quick Coupling For DHS-DCS System DHS-DCS Direct Measuring Device Screw Holding Sleeve For 2.4 Wise-lock Screw Periosteal Elevator Curved Stopper For Drill Bit Dia4.3mm Poly-Axial Reduction Screwdriver Trays For Expert Tibia Nailing System Instrument Trays Hohmann Retractor, Width15.5mm Rod Cutter Forcep Screw Holding Sleeve for 2mm Cortical Screws Handle With Quick Coupling (Straight) Reamer Head, Dia9.5mm Stopper (For Dia3.2mm Drill Bit) Round Scraper, 7mm Osteotome Plate Holder Hohmann Retractor, 6.5mm Protection Sleeve 11/8.6mm (For Dia4.8mm Locking Bolt) Torque limited Screwdriver, 0.8Nm Trocar Dia4.3mm Implant Inserter (Short) Guide Wire, Dia1.2 x 150mm Reamer Head, Dia12mm Wise-Lock Drill Sleeve 1.5mm, for Drill Bit, Dia1.1mm Drill Bit, Dia2.4 x 140mm Compactor, 12mm Reduction Forceps, Serrated, Speed Lock, 210mm DHS Angle Guide Degree 130 Allen Key, Hex 3mm Steilization Container 520mm x 250mm x 100mm Curved Awl DHS-DCS lmpactorType-11 Screwdriver Shaft, T4 For 1.5mm Screws Graft Impactor Mesh Impactor (Angled) Cutting Forceps Depth Gauge, Measuring range upto 100mm Allen Wrench, Hex 5mm Bending Template Scraper, 9mm Curved Trial Pusher Periosteal Elevator Curved, 8mm Tap, 6mm Screw Driver, Self Retaing (for Screw Removal), 3.5mm DHS-DCS lmpactorType-1 Periosteal Elevator, Curved,16mm Wise-Lock Drill Sleeve 2mm, for Drill Bit, Dia1.5mm Double Periosteal Elevator, Flat Marker (R) Countersink, for Dia 4.5/6.5mm Screws Countertorque Rod Pusher External Fixator Open Single Pin Clamp 3.5mm Bending Template Mono Drilling Guide Drill Sleeve 8/5.3mm (For Positioning Rod) Torque Screw Driver - 2mm Tip, 0.8Nm Graft Impacter Hex Rod Rotation Forceps HSS Drill Bit Dia2.5, Metal Bone Impator Rod Pusher Distal Screw Device (Static/ Dynamic Locking) Drill Bit Quick Coupling, Dia2mm x 100mm Double Drill Guide, Dia1.8/2.4 Measure, 14-16mm Reduction Device Quick Coupling Shaft Dual Drilling Guide Drill Bit Quick Coupling Dia1.1mm x Length 75/61mm, 2-flute Torque Screw Driver, 2mm, 0.8Nm "Star Drive" Drill Guide for Neutral and Loaded Position, LC-DCP Dia3.2mm Self Centering Bone Holding Forcep Speed Lock Curettes, Ring Depth Gauge, measuring range upto,110mm Kirschner Wire with Trocar Tip Both End Dia2.5mm x 250mm Guide Wire With Threaded Trocar Tip Dia2.5mm x 250mm x 10mm Thread Length Sleeve With Handle Double Periosteal Elevator, Round Scraper, 8mm Drill Bit Quick Coupling with Stopper, Dia2.8mm x Length 165mm Drill Bit Plain Shank/Jacob Chuck End Dia4.3mm x 300mm Bolt For Distal Aiming Device VERTAUX - 5.5 Pedicle Screw Instrument Set Cervical Plate and Screw Box Pedicle Straight Probe Insert Drill Sleeve, Dia 4.5/3.2mm Holding Sleeve 2.7mm for Cortical Screws Retractor, 6.5mm Proximal Aiming Device (For Dia4.8mm Locking Bolt) Drill Bit, Dia1.8 x 140mm Knife Cervical Bladed Cage Holder Rod Holder Curved Handle With Quick Coupling Hexagonal Screwdriver SW2 Cannulated Awl For Expert Tibia Nail Universal Screw Driver, Hex 6.5mm, Ball Tip (For Nail Holding Bolt) Retractor, 6mm Pedicle Curved Probe Screw Holding Forceps, Screw Holding Sleeve for 1.5mm Cortical Screws Round Scraper, 11mm Inserion Handle Container Instrument Case For Samll Fragment Star Screw Driver For 1.5mm Screws T-handle Distal Bolt, Hex-5mm (For Distal Targeting Device) Hexagonal Screw Driver Shaft - 2.5mm Tip, Quick Coupling Guider For Vairable Angle Plate, Dia1.8mm Threaded Drill Guide, Dia3.5mm for drill bit 2.8mm Measure, 18-20mm Periosteal Elevator with Silicon Handle, Curved, 6mm Distractor Guide Wire With Threaded Trocar Tip Dia1.5mm x Length 150mm x Thread Length 5mm External Fixator Single Clamp-Deluxe Depth Gauge, measuring range upto,100mm Retractor, 15mm Drill Bit Plain Shank/Jacob Chuck End Dia3.2mm x Length 250 (For Dia4.8mm Locking Bolt) Compression Bolt Dia4mm Multiaxial Screwdriver Locking Bolt (For Distal Aiming Bar) Reamer Head, Dia12.5mm Connecting Shaft Laminectomy Punches Bending Pin with Thread for 2mm Wise-Lock Plates Drill Sleeve 8/4mm (For Dia4mm Drill Bit) Double Drill Guide, 6/8 Bending Iron Pair Radiographic Ruler for Expert Tibia Nail Positioning Rod 8.1/5.2mm Trial, 9mm Screw Holding Sleeve For 2.7 Cortical Screw Direct Measuring Device, Length upto 120mm Drill Bit Quick Coupling,Dia3.5mm x 112mm Drill Bit Quick Coupling,Dia4.5mm x 145mm 9mm Plate Hook Forceps Block For Connecting Shaft Guide For Cage Trial, 7mm Bone Tap Quick Coupling, Cortical Screws, 4.5mm Marker Inserter Depth Gauge, Length upto 100mm Template 450mm Trial, 6mm OSTEOBONE Multiaxial Instrument Set Drill Sleeve Dia8.1/2.5mm Impactor, Round Trimming Rasp Drill Guide for Neutral and Loaded Position, DCP Dia4.5mm/3.2mm 2.4 Drill Bit, 16mm Rod Bender Forcep Outer Drill Sleeve 10/8.1mm (For Distal Targeting Device) Guide wire without Ball Tip Dia 2.5 x Length 1000mm - Nitinol Counter Torque Hexagonal Screw Driver with Holding Sleeve - 2.5mm Tip Hohmann Retractor, 15.5mm Trocar Dia2.5mm Reamer Head, Dia13.5mm Allen Key 3mm External Fixator Twin adjustable Clamp Curved Guide Wire with Threaded Trocar Tip, Dia1.2mm x Length 230mm x 10mm Thread Length Self Centering Bone Holding Forcep, Speed Lock, 190mm Steilization Container 520mm x 250mm x 130mm Elevator Universal Drill Guide 2.4/1.8mm Mono-Axial Pedicle Screwdriver Star screw Driver Shaft, T8 In-Situ Bender (L) 4.5mm Bending Template Drill Guide, Dia2.5/3.5mm Hexagonal Screw Driver Shaft - 3.5mm Tip Long , Quick Coupling Tap, 4.5mm Locking Device Position Rod Double Drill Guide, Dia2/2.7 Nut For Hammer Guide Shaft Screwdriver, Sw 3 Countersink For 2/2.4/2.7mm Screws Marker (L) Trial, 14mm x 22mm HSS Drill Bit, Metal, Dia3.5mm Insert For Distractor Pin Stabilizing Device (For Positioning Rod) Screwdriver 2mm Holding Sleeve 2.4/2.7mm Locking Screws Screw Tray For Small fragment Screws Root Retractor (Large) Marker, Left Trial, 10mm Reduction Forceps With Points, Small Template 120mm Tap, HA 2.7 External Fixator Transverse Clamp Countersink for Dia2/2.4/2.7mm Screws Trocar For Protection Sleeve Dia8mm Compactor, 18mm Drill Guide,Dia2/2.7mm Quick Coulping Shaft Guide Sleeve for Dia1.2mm K. Wires Curettes, Straight Reamer Head, Dia 7.5,mm T-Handle with Quick Coupling Impactor, Flat Drill Sleeve 8.5/3.3mm (For Dia3.2mm Drill Bit) Aura Cage (TLIF) Instrument Set Reduction Forcep, Pointed, Ratchet Lock, 240mm Depth Gauge, Length upto 90mm (For Dia4.8mm Locking Bolt) Depth Gauge, Upto 60mm Straight Serrated Cup Curette (Short) Trial Case Double Drill Guide,Dia4.5/3.2mm Trail, 6mm x 24mm Hook Probe Guide Sleeve for Dia 2mm K. Wires Screw Driver Holding Sleeve Long Coupling Screw For DHS DCS Screw Removal Trial, 8mm x 22mm Drill Bit Quick Coupling Dia1.8mm x Length 110/82mm, 2-flute Retractor, 10mm Guide Wire with Threaded Trocar Tip, Dia1.5mm x Length 150mm x 5mm Thread Length DHS Angle Guide Degree 135 Hexagonal Screw Driver Shaft- 3.5mm Tip, Quick Coupling 2.4mm Container Allen Key for Dill Bit Stopper Dia3mm Threaded Drill Guide, Dia2.7mm for drill bit 2mm Kirschner Wire with One Side Trocar Tip, Dia1.5mm x 150mm Radiographic Ruler Reamer Head, Dia8.5mm Pedicle Screw Measuring (White) Reduction Forcep, Pointed, Ratchet Lock, 180mm Entry Cutter For Expert Tibia Nail Dia 12mm Star Screwdriver with Quick Coupling (Long) Driver For Nail Holding Bolt Reamer Head, Dia10.5mm Tap, 7mm Depth Gauge (With Protector) Distal Aiming Bar DHS-DCS Centering Sleeve, Short Countersink, for Dia4.5/6.5mm Screws Drill Bit Quick Coupling,Dia2.5mm x 112mm Drill Bit Quick Coupling Dia2.7mm x Length 102mm, 2-flute Compressor Tap, for Cancellous Screws, Dia6.5mm Lumbar Cage Intrument Set Universal Drill Guide 2.7/2mm Intervertebral Disc (IVD) Rongeurs, Curved Slap Hammer Impactor Marker, Right Screwdriver Sleeve Double Drill Guide 1.5/1.1mm Fixation Pin Screwdriver Shaft "Star Drive" Bending Pin with thread for 2.4/2.7mm Wise-Lock Plates Torque Limiter Handle, 10Nm Screw Holding Sleeve For 2.4 Cortical Screw Reduction Forceps, Pointed, Small Round Scraper, 13mm Toque Screw Driver Handle Threaded Inserter Reducer Trocar for Sleeves 8mm (For Distal Targeting Device) Plates Files Round Scraper, 9.5mm x 8.5mm Bending Forceps Mesh Impactor (Straight) Reduction Forceps With Points, Serrated Drill Guide for Neutral and Loaded Position, LC-DCP Dia2.5mm Tap for Dia 4.5mm Cortical Screws, Quick Coupling Plate Bender Hohmann Retractor, Width 6.5mm Rod Bender, Right Locking Bolt For Proximal Aiming Bar Guide Wire with Threaded Tip, Dia2mm x Length 150mm x 8mm Thread Length External Fixator Compression Distraction Device Implant Support Universal Drill Guide, 4.5/3.2mm Pull Scraper Screw Driver with T-Handle, Hex 3.5mm Guide Wire, Dia1.5 x 150mm Cutting Plier (for pins and plates) Cannulated Step Drill Bit With Stopper (For Anti-Rotation Screw) Dia6.5/2.5mm Outer Drill Sleeve 11/8.2mm DHS-DCS Wrench Drill Guide for Neutral and Loaded Position, Dia3.5mm Guide Wire, Dia2.5mm x Length 340mm Round Scraper, 15mm Curved Curettes, Right Mono-Axial Reduction Screwdriver Vertaux - Occipital Instrument Set Crosslink Hooks Holder Drill Bit Plain Shank/Jacob Chuck End Dia4mm x Length 300mm Power Gripper Depth Gauge, measuring range upto 50mm, for 2.4mm/2.7mm Screws Trial, 5mm Connecting Rod - Impactor Stright probe Periosteal Elevator with Silicon Handle Curved, 6mm Trial, 14mm x 26mm Bone Tap, Quick Coupling for Cancellous Screws, Dia4mm Entry Reamer 14.3mm/3.3mm 3mm Template Curved Curettes, Left Bending Pin with Thread 2.4/2.7mm Wise-Lock Plates Drill Guide for Neutral and Loaded Position, DCP Dia2.5mm 2.4 Drill Bit, 14mm Self Centering double drill guide,Dia4.5/3.2mm Tap, HA 2.4 4mm Tap Screw Tray Periosteal Elevator, Curved, 8mm Raspatory, Straight Cervical Cage Instrument Set Protection Drill Sleeve 10/8.1mm Depth Gauge, measuring upto 30mm Guide wire with Ball Tip Dia 2.5/3.65mm x Length 1000mm - Nitinol Trial, 4mm Depth Gauge, measuring upto 50mm Quick Coupling Handle Round Scraper, 8.5mm x 7.5mm Hohmann Retractor, Dia16mm Mesh Cutter Depth Gauge Mesh Trays Tray Hexagonal Screw Driver with Holding Sleeve-2.5mm Tip Trial, 12mm x 26mm Hex Screwdriver Countersink, for Dia3.5/4mm Screws, Quick Coupling Scraper, 7mm Reduction Forceps, Pointed, Ratchet Lock, 210mm 2.4 Drill Bit, 12mm Double Drill Guide, 10/12 Strar Head Screwdriver Shaft,T8 Reamer Head, Dia 8mm Mesh Tray DCS Angle Guide Degree 95 2mm Container Bending Pliers Hohmann Retractor, Dia44mm Screw tray For Small Fragment Wise Lock System Bone Filler Device Plunger Kirschner Wire with One Side Trocar Tip, Dia2mm x 150mm In-Situ Bender (R) Large Bending Template Periosteal Elevator, Curved, Dia16mm Threaded Guide Wire, Dia2.5mm x Thread Length 10mm x Length 340mm Screw Holding Sleeve For 2.4mm Wise-lock Screw Trephine Drill Bit With Stop, 14mm Holding Sleeve for 2.4/2.7mm Locking Screws Guide Wire Without Ball Tip Dia2.5mm x Length 1000mm -Nitinol Star Screw Driver For 2.4/2.7mm Screws External Fixator Small Single Clamp 4 X 2.5 mm Modified Trial, 11mm Probe Threaded Drill Guide 5, for Drill Bit Dia4.3mm Measure, 22-25mm Screw Measuring Gauge, Length upto 90mm Container For Hand & Foot Instrument & Implant Set Proximal Aiming Device (For Dia4.4mm Locking Bolt) Screw Tray for Large Fragment Tap for Dia4.5mm Cortical Screws, Quick Coupling Screwdriver Shaft, T6, for 2mm Screws Handle with Mini Quick Coupling DHS Tripple Reamer Slap Plate Bolt For Proximal Aiming Device Periosteal Elevator, Round Holding Sleeve for 2.4mm Cortical Screws Drill Sleeve Insert, Dia3.5/2.5mm Screw Holding Sleeve for 2mm Locking Screws Wrench, 3.2mm Poly-Axial Pedicle Screwdriver Double Drill Guide, Dia6.5/3.2mm Steilization Container 440mm x 210mm x 100mm Hexagonal Screw Driver with Holding Sleeve, 3.5mm Tip DHS-DCS Tap For DHS Instrument Set Reamer Head, Dia9mm Guide Wire with Threaded Tip, Dia 2mm x Length 230mm x 10mm Thread Length Double Drill Guide, Dia4.5/3.2mm Screwdriver Shaft, T8 for 2.4mm/2.7mm Screws Torque Limiter, 0.4Nm, with AO quick coupling (Optional) Hexagonal Screw Driver Shaft - 2mm Tip, Quick Coupling Round Scraper, 9mm External Fixator Tube to Tube Clamp Insert Drill Sleeve, Dia4.5/3.2mm Probe Hook, Graduated, 1mm Hook, Dia 2.3mm, 140mm Working Length Dia 1.2mm X 150mm Threaded Guide wire Ratchet Handle For Hudson Coupling Screwdriver Shaft Smilie Miniscotome, 5mm Wide, Straight Cutting Edge Hook Probe and Retractor, 40mm Working Length, 2mm Hook Length - 90 Degree Graft Sizer, 6mm to 12mm (0.5mm steps) PCL Rasp, Curved Smart Hook Suture passer, Right Needle With Lateral Opening For ESCORPIAN Suture Passer Tunnel Plug, 9-10mm PCL Straight Currete, Closed End Tunnel Notcher PCL Curved Curette Quick Coupling T-Handle For Tunnel Dilator Smilie Miniscotome, 3mm Wide, Straight Cutting Edge Screwdriver Shaft For Titanium Interference Screw, T25 Star Driver, Hudson Coupling Graft Sizer, 4mm to 7mm (0.5mm Steps) RetroConstruction Drill Guide Handle, Side Release Tunnel Plug, 7-8mm Dia 4.5 Spade drill Pin Hook Probe and Retractor, 40mm Working Length, 3mm Hook Length - 45 Degree Dia1.2mm X 180mm Blunt tip Guide wire ESCORPIAN Suture Passer Smart Hook Suture passer, Straight Trocar Tip Obturator - Curve Depth Gauge For Knee ACL/PCL Instrument Probe Hook, Graduated, 1mm Hook, Dia 1.5mm, 75mm Working Length PCL Suture Pusher Smilie Miniscotome, 7mm Wide, Straight Cutting Edge Drill Guide Bullet Dia 2.4mm Passing Pin Graft Sizer, 6mm to 9mm (1mm Steps) Graft Station Board Dia1.5mm K-Wire Trocar Tip Obturator, Long Trocar Tip Obturator Screwdriver Shaft For Polymer Interference Screw, Hudson Coupling Nitinol Guide Wire Dia 1.2mm x Length 300mm (For Interference Screws) Tunnel Plug, 8-9mm Passing Pin, Dia 2.4mm x 250mm Pin, Trocar-Tip, Dia 2.4mm x 355mm

Establishment Types

Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device