Auxein medical Private limited

FDA Device Registration & Listing · Sonipat Haryana, IN · Registration 3010303097

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3010303097
FEI Number
3010303097
Entity Name
Auxein medical Private limited
City/State/Country
Sonipat Haryana, IN
Establishment Address
Plot No.168,169,170 Phase-IV, Sector 57, Kundli Industrial area,, HSIIDC Sonipat- 131028, Haryana, INDIA, Sonipat Haryana 131028, IN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Auxein Medical Pvt Ltd (Owner Number: 10046810)
Owner / Operator Contact Address
Plot No.168,169,170 Phase-IV, Sector 57, Kundli Industrial area, HSIIDC Sonepat- 131028, Haryana, INDIA, HSIIDC Sonipat- 131028, Haryana, INDIA, Sonipat, IN-HR 131028, IN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered 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. 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 AUXEIN MEDICAL PVT LTD Clavicle and Scapula System Auxein Medical Pvt. Ltd. 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 Auxein Medical Pvt. Ltd. Auxein Medical Pvt. Ltd. Auxein Medical Pvt. Ltd. Hammer Humerus and Ulna System Auxilock Titanium Interferece Screw Auxein Medical Pvt. Ltd. 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 Auxein Medical Pvt. Ltd. Auxein Medical Pvt. Ltd. 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 Auxein Medical Pvt. Ltd. 2.4 mm Radius System Auxein Medical Pvt. Ltd. Auxein Medical Pvt. Ltd. Auxein Medical Pvt. Ltd. AUXEIN MEDICAL PVT LTD Auxilock Draw Tight Suture Based Anchor AUXEIN MEDICAL PVT LTD 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 Auxein Medical Pvt. Ltd. Auxein Medical Pvt. Ltd. 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 Mini Bone Curette 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 Auxein Medical Pvt. Ltd. AUXEIN MEDICAL PVT LTD Auxein Medical Pvt. Ltd. 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 Auxein Medical Pvt. Ltd. Auxein Medical Pvt. Ltd. Auxein Medical Pvt. Ltd. Sliding base Auxein Medical Pvt. Ltd. Meniscus Root Marking Hook FlyKuter Guide Bullet AUXEIN MEDICAL PVT LTD AUXEIN MEDICAL PVT LTD AUXEIN MEDICAL PVT LTD Auxein Medical Pvt. Ltd. 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 Auxein Medical Pvt. Ltd. AUXEIN MEDICAL PVT LTD 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 Medical Pvt. Ltd. Auxein Medical Pvt. Ltd. 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 Auxein Medical Pvt. Ltd. Tibia and Fibula System Auxein Medical Pvt. Ltd. Auxein Medical Pvt. Ltd. AUXEIN MEDICAL PVT LTD Staple Impactor AUXEIN MEDICAL PVT LTD Auxein Medical Pvt. Ltd.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2023-02-16
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-02-16
HTO Reamer Orthopedic Class 1 888.4540 2016-01-18
HWX Tap, Bone Orthopedic Class 1 888.4540 2016-01-18
HTF Curette General, Plastic Surgery Class 1 878.4800 2023-08-02
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-05-10
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2024-05-10
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2024-05-10
KTW Appliance, Fixation, Nail/Blade/Plate Combination, Single Component Orthopedic Class 2 888.3030 2024-05-10
LRP Tray, Surgical General, Plastic Surgery Class 1 878.4800 2019-02-28
HWD Starter, Bone Screw Orthopedic Class 1 888.4540 2016-01-18
EJB Handle, Instrument, Dental Dental Class 1 872.4565 2019-02-28
JDZ Mixer, Cement, For Clinical Use Orthopedic Class 1 888.4210 2016-01-18
HXX Screwdriver Orthopedic Class 1 888.4540 2016-01-18
FMH Container, Specimen, Sterile Pathology Class 1 864.3250 2019-02-28
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2024-12-10
HWK Trephine Orthopedic Class 1 888.4540 2016-01-18
HXB Probe Orthopedic Class 1 888.4540 2016-01-18
HWR Driver, Prosthesis Orthopedic Class 1 888.4540 2016-01-18
HXO Pusher, Socket Orthopedic Class 1 888.4540 2016-01-18
HWW Countersink Orthopedic Class 1 888.4540 2016-01-18
FZY Hammer, Surgical General, Plastic Surgery Class 1 878.4800 2023-08-02
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2023-02-16
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-02-16
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2021-12-13
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-12-13
KIL Positioner, Socket Orthopedic Class 1 888.4540 2016-01-18
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2018-05-07
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2018-05-07
KQX Goniometer, Ac-Powered Orthopedic Class 1 888.1500 2016-01-18
HWO Skid, Bone Orthopedic Class 1 888.4540 2016-01-18
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2019-02-28
HWP Punch, Femoral Neck Orthopedic Class 1 888.4540 2016-01-18
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-04-08
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2022-04-08
HXS Twister, Wire Orthopedic Class 1 888.4540 2016-01-18
HXC Wrench Orthopedic Class 1 888.4540 2016-01-18
HSS Halter, Head, Traction Orthopedic Class 1 888.5890 2016-01-18
GDZ Handle, Scalpel General, Plastic Surgery Class 1 878.4800 2019-02-28
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2023-02-16
MOQ Battery, Replacement, Rechargeable General, Plastic Surgery Class 1 878.4820 2019-02-28
HWJ Awl Orthopedic Class 1 888.4540 2016-01-19
HWL Set, Hollow Mill Orthopedic Class 1 888.4540 2016-01-18
HXZ Cutter, Wire Orthopedic Class 1 888.4540 2016-01-18
NBH Accessories, Arthroscopic Orthopedic Class 1 888.1100 2016-01-19
HXQ Crimper, Pin Orthopedic Class 1 888.4540 2016-01-18
FRI Scale, Stand-On, Patient General Hospital Class 1 880.2700 2019-02-28
HRR Scissors, Orthopedic, Surgical Orthopedic Class 1 888.4540 2016-01-18
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2023-02-16
CCO Bed, Rocking, Breathing Assist Anesthesiology Class 2 868.5180 2019-03-08
HXE Fork Orthopedic Class 1 888.4540 2016-01-18
HTP File Orthopedic Class 1 888.4540 2016-01-18
HWQ Passer Orthopedic Class 1 888.4540 2016-01-18
HWT Template Orthopedic Class 1 888.4800 2016-01-18
HTS Knife, Orthopedic Orthopedic Class 1 888.4540 2016-01-18
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2023-08-02
HWM Osteotome General, Plastic Surgery Class 1 878.4800 2019-02-28
BRY Cabinet, Table And Tray, Anesthesia Anesthesiology Class 1 868.6100 2019-02-28
FRW Scale, Patient General Hospital Class 1 880.2720 2019-02-28
OCJ Spinal Channeling Instrument, Vertebroplasty Orthopedic Class 1 888.4540 2016-01-18
HTX Rongeur Orthopedic Class 1 888.4540 2016-01-18
HRT Stripper, Surgical Orthopedic Class 1 888.4540 2016-01-18
HWN Instrument, Compression Orthopedic Class 1 888.4540 2016-01-18
KEY Stainer, Tissue, Automated Pathology Class 1 864.3800 2019-02-28
HTE Elevator General, Plastic Surgery Class 1 878.4800 2023-08-02
HSR Unit, Traction, Hip, Non-Powered, Non-Penetrating Orthopedic Class 1 888.5890 2016-01-18
LGG Instrument, Cast Application/Removal, Manual Orthopedic Class 1 888.5980 2016-01-18
JDS Nail, Fixation, Bone Orthopedic Class 2 888.3030 2020-06-22
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2020-06-22
HWB Extractor Orthopedic Class 1 888.4540 2016-01-18
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2023-02-16
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-02-16
KIH Dispenser, Cement Orthopedic Class 1 888.4200 2016-01-18
HXP Instrument, Bending Or Contouring Orthopedic Class 1 888.4540 2016-01-18
GES Blade, Scalpel General, Plastic Surgery Class 1 878.4800 2019-02-28
HWA Impactor Orthopedic Class 1 888.4540 2016-01-18
FOX Stand, Infusion General Hospital Class 1 880.6990 2019-02-28
HXG Tamp Orthopedic Class 1 888.4540 2016-01-18

Official Correspondent

No official correspondent registered.

US Agent Details

Lee Strong Business: 510K FDA Inc. Email: lee@510kfda.com Phone: (386) 8466037

Related Public Records

Same Entity

Auxein Medical Pvt Ltd
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K042598 Zimmer, Inc. PERIARTICULAR LOCKING PLATES AND SCREWS, 2357 AND 2359 SERIES 2004-10-29
K190842 Jiangsu Trauhui Medical Instrument Co., Ltd. Comus Locking Plate systems 2020-02-03
K130510 Arthrex, Inc. ARTHREX COMPRESSION PLATES 2013-09-25
K202803 Newclip Technics Activmotion S DTO 2021-12-16
K062348 Medtronic Neurosurgery TIMESH SELF DRILLING SCREW 2006-09-08

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0034-2022 Flower Orthopedics Corporation 2
Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
Z-0014-2014 Synthes USA HQ, Inc. 2
Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013 Orthohelix Surgical Designs Inc 2
OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0026-2016 Ortho Solutions Inc 330 Franklin Tnpk 2
Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
Z-0027-2013 Orthohelix Surgical Designs Inc 2
OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010303097. Last updated year: 2026. Please use registration number 3010303097 when referencing this establishment in official correspondence.
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