BIOMET MICROFIXATION

FDA Device Registration & Listing · Jacksonville, FL, US · Registration 1032347

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
1032347
FEI Number
1032347
Entity Name
BIOMET MICROFIXATION
City/State/Country
Jacksonville, FL, US
Establishment Address
1520 Tradeport Dr, Jacksonville, FL 32218, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
BIOMET MICROFIXATION (Owner Number: 1032347)
Owner / Operator Contact Address
1520 TRADEPORT DR., --, Jacksonville, FL 32218, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Needleholder Microvascular Needleholder Neuro System 1mm System 1.5mm System CMF System Forceps 2.1 x 255mm Drill, 22mm Stop Scottish Rite Tongue Depressor Reconstruction System with Modular Screw TMS System Sternal Closure System SternaLock Blu SternaLock STERNALOCK 360 TMJ Band Pusher CMF System RibFix Advantage Articulator Biomet Microfixation Sternalock 2mm System CMF System Neuro System 1mm System 1.5mm System Headlight WRENCH Septum Gouge Gouge Tendon Gouge Screwdriver Blade Caliper IMF Guide Double Ended Drill Guide Drill Guide LactoSorb Drill Guide Guide Sleeve RIBFIX BLU RibFix Blu RibFix Blu Screws Pusher Condyle Stripper Periosteal Stripper Stripper Tessier Forceps Jewelers Forceps Forceps Adson Forceps Expander 1.5mm System 1mm System Biomet Microfixation Neuro Plating System CranioCurve Pre-bent Plates with Virtual Surgical Planning VSP Virtual Surgical Planning LactoSorb Water Bath Sterile Drape Orthodontic Band Rubber Band Condyle Retractor TMJ Retractor Retractor Cheek Retractor Lumenon Fiber Optic Cable LactoSorb Heat Pen Lorenz Wire Twister Wire Twister Wire Twisting Forceps Nasal Elevator Elevator SternaLock Blu SternaLock Brush Mini-Friedman Rongeur Beyer Rongeur Luer Rongeur Zaufal-Jansen Rongeur Rongeur Friedman Rongeur Seldin Root Pick Extractor Rees Insulated Forcep Instrument Containers Plate Bender Bender Ligature Wire Lorenz Blue Device SternaLock SternaLock Blu Mouth Gag Nasal Speculum Dental Mirror SEEG Short/Long Bolt Driver PreBent Plates Mandibular Fracture/Reconstruction Devices Bur Wire Cutter Cutter Wire Arch Bar Prestretched Wire RibFix Blu Aesculap SterilContainer Micro Forceps Adkins Strut Instrument Containers BIO COMP MINI MILL Bone Rasp Rasp TMJ Diamond Rasp SterileTrac Sterile Bone Plates and Screws ArthroSimplicity Kit InnerVue Scope Procedure Kit Pectus Introducer Pectus Bar Flipper Bi-Phase Instrumentation 316 Wire, Multiple Hand Splint Anti-Reticulin Antibody Test Lacrimal Probe SternaLock Blu RibFix Blu Biomet Microfixation Thoracic Fixation System RibFix Advantage Scissors Face Lift Scissors Micro Scissors Retractor QC Removal Tool Mouth Prop VENAPAX XL Self Drilling IMF Screw Pectus Blu System Bi Phase Palate Scissors Scissors Osteotome Chisel CURETTE Walter Scope Holder WalterLorenz Surgical Assist Arm Scope Holder Gauze Director Ligature Tucker Nasal Rasp Diamond Rasp Rasp Needle Guide LactoSorb Heat Pack Extracting Forceps Bone Tamp Twist Drill OmniMax Spindown Rapidflap Tap CURETTE SternaLock Blu SternaLock Retractor Lactosorb Water Bath 1mm System 1.5mm System 2mm System Add on Condyle WalterLorenz Surgical Assist Arm Walter Drape with Button RibFix Blu Thoracic Fixation System MIMIX QS MIMIX QUICK SET Sternal Closure System Pectus Blu Support Bar System Pectus Blu TruLink Tongue Depressor Chisel Osteotome RibFix Advantage Lorenz Distraction System WalterLorenz Surgical Assist Arm Pectus Bar System Self Drilling Screw Periodontal Probe Basin Curette Dental Gauge Forceps Ear Forceps Septum Forceps SternaLock 360 Sternal Closure System SternaLock 360 SL 360 Spatula Aesculap SterilContainer Aesculap SterilContainer System Elevator Dental Elevator Periosteal Elevator Perforator Carrier Retractor Byrd Screw Hammer Mallet Bone File Cannula Virtual Surgical Planning VSP Pre-bent Plates with Virtual Surgical Planning POWER DRIVER iQ Intelligent Driver 2mm System CMF System Neuro System 1.5mm System 1mm System Pectus Bar Stabilizer Pectus Bar System Nasal Scissors Septum Scissors Twist Drill Fracture/Reconstruction Plating 2.3mm System 2mm System TMS System OmniMax MMF System Explorer Wire Passer Dissector Scalpel Blade Caliper Button Knife Nasal Knife Knife MIMIX Dissector SYRINGE CHIP BLOWER OnPoint HTR-PMI RibFix Titan™ Fixation System Lactosorb Plate Templates TMJ Mandibular or Fossa Trial Pectus Bar Template Biomet Microfixation Bone Plate Templates Nasal Dilator

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HXK Holder, Needle; Orthopedic Orthopedic Class 1 888.4540 2003-09-16
JEY Plate, Bone Dental Class 2 872.4760 2012-05-11
HTD Forceps General, Plastic Surgery Class 1 878.4800 1992-12-14
HBE Drills, Burrs, Trephines & Accessories (Simple, Powered) Neurology Class 2 882.4310 2023-04-19
KBL Depressor, Metal Tongue, Surgical Ear, Nose, Throat Class 1 874.4420 2019-07-17
JEY Plate, Bone Dental Class 2 872.4760 1992-12-14
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2003-09-16
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2017-05-17
LZD Joint, Temporomandibular, Implant Dental Class 3 872.3940 2007-12-04
ECR Setter, Band, Orthodontic Dental Class 1 872.4565 2021-02-02
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 1998-08-14
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-09-20
EJP Articulators Dental Class 1 872.3150 1992-12-14
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2012-09-25
JEY Plate, Bone Dental Class 2 872.4760 1992-12-14
HPP Headlamp, Operating, Battery-Operated Ophthalmic Class 1 886.4335 2016-02-05
HXC Wrench Orthopedic Class 1 888.4540 2001-04-20
GDH Gouge, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 1992-12-14
GFA Blade, Saw, General & Plastic Surgery, Surgical General, Plastic Surgery Class 1 878.4820 2003-09-16
KTZ Caliper Orthopedic Class 1 888.4150 2021-02-02
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2003-09-16
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2017-05-17
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2017-05-17
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2015-07-13
ECS Pusher, Band, Orthodontic Dental Class 1 872.4565 2003-09-16
HRT Stripper, Surgical Orthopedic Class 1 888.4540 2003-09-16
GEN Forceps, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2003-09-16
FZW Expander, Surgical, Skin Graft General, Plastic Surgery Class 1 878.4800 2003-09-16
HBW Fastener, Plate, Cranioplasty Neurology Class 2 882.5360 2013-02-08
GXR Cover, Burr Hole Neurology Class 2 882.5250 2013-02-08
GWO Plate, Cranioplasty, Preformed, Alterable Neurology Class 2 882.5320 2013-02-08
DZJ Driver, Wire, And Bone Drill, Manual Dental Class 2 872.4120 2015-03-25
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2015-03-25
JEY Plate, Bone Dental Class 2 872.4760 2015-03-25
KKX Drape, Surgical, Antimicrobial General, Plastic Surgery Class 2 878.4370 2012-06-04
ECI Band, Elastic, Orthodontic Dental Class 1 872.5410 2010-11-29
EIG Retractor, All Types Dental Class 1 872.4565 2003-09-16
EQH Source, Carrier, Fiberoptic Light Ear, Nose, Throat Class 1 874.4350 2003-09-16
FZT Cutter, Surgical General, Plastic Surgery Class 1 878.4800 2003-09-16
HXS Twister, Wire Orthopedic Class 1 888.4540 2003-09-16
KAD Elevator, Ent Ear, Nose, Throat Class 1 874.4420 2003-09-16
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 1998-08-14
GEC Brush, Scrub, Operating-Room General, Plastic Surgery Class 1 878.4800 2011-01-21
HTX Rongeur Orthopedic Class 1 888.4540 2012-12-19
DZN Instruments, Dental Hand Dental Class 1 872.4565 2012-12-17
HWB Extractor Orthopedic Class 1 888.4540 2012-02-27
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2012-12-17
LRP Tray, Surgical General, Plastic Surgery Class 1 878.4800 2003-10-16
HXW Bender Orthopedic Class 1 888.4540 2008-09-18
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2013-01-21
MQN External Mandibular Fixator And/Or Distractor Dental Class 2 872.4760 2013-01-30
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2015-10-29
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2015-10-29
KBN Gag, Mouth Ear, Nose, Throat Class 1 874.4420 2003-09-16
EPY Speculum, Ent General, Plastic Surgery Class 1 878.1800 2003-09-16
EAX Mirror, Mouth Dental Class 1 872.4565 2003-09-16
GXL Screwdriver, Skullplate Neurology Class 1 882.4900 2023-07-06
JEY Plate, Bone Dental Class 2 872.4760 1992-12-14
EQJ Bur, Ear, Nose And Throat Ear, Nose, Throat Class 1 874.4140 2003-09-16
HXZ Cutter, Wire Orthopedic Class 1 888.4540 2003-09-16
DZC Wire, Orthodontic Dental Class 1 872.5410 2003-09-16
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2016-04-06
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2016-04-06
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2016-05-05
HNR Forceps, Ophthalmic Ophthalmic Class 1 886.4350 2012-03-02
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2012-07-03
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2003-09-16
LYS Bone Mill Orthopedic Class 1 888.4540 2003-09-16
GAC Rasp, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2003-09-16
JEY Plate, Bone Dental Class 2 872.4760 1992-12-14
KDD Kit, Surgical Instrument, Disposable General, Plastic Surgery Class 1 878.4800 2008-01-08
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2004-12-10
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2011-01-25
DBL Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control Immunology Class 2 866.5660 2008-04-07
NOC Splint, Extremity, Non-Inflatable, External, Non-Sterile General, Plastic Surgery Class 1 878.3910 2016-11-11
HNL Probe, Lachrymal Ophthalmic Class 1 886.4350 2003-09-16
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2015-03-27
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-06-18
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-06-18
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2021-06-18
LRW Scissors, General, Surgical General, Plastic Surgery Class 1 878.4800 2003-09-16
EIF Accessories, Retractor, Dental Dental Class 1 872.4565 2003-09-16
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2025-01-03
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2012-05-16
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2026-06-04
JEY Plate, Bone Dental Class 2 872.4760 2018-07-26
EGN Scissors, Surgical Tissue, Dental Dental Class 1 872.4565 2003-09-16
EML Chisel, Bone, Surgical Dental Class 1 872.4565 2003-09-16
KAP Curette, Nasal Ear, Nose, Throat Class 1 874.4420 2003-09-16
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2019-06-11
OCV Endoscope Holder Gastroenterology, Urology Class 2 876.1500 2019-06-11
ECP Instrument, Ligature Tucking, Orthodontic Dental Class 1 872.4565 2003-09-16
KBA Rasp, Nasal Ear, Nose, Throat Class 1 874.4420 2003-09-16
GDF Guide, Needle, Surgical General, Plastic Surgery Class 1 878.4800 2003-09-16
IMD Pack, Hot Or Cold, Disposable Physical Medicine Class 1 890.5710 2012-06-04
EMG Forceps, Tooth Extractor, Surgical Dental Class 1 872.4565 2003-09-16
HXG Tamp Orthopedic Class 1 888.4540 2012-12-17
HBE Drills, Burrs, Trephines & Accessories (Simple, Powered) Neurology Class 2 882.4310 2007-02-05
DZL Screw, Fixation, Intraosseous Dental Class 2 872.4880 2021-09-24
JEY Plate, Bone Dental Class 2 872.4760 2021-09-24
GXN Plate, Cranioplasty, Preformed, Non-Alterable Neurology Class 2 882.5330 2009-12-17
HWX Tap, Bone Orthopedic Class 1 888.4540 2003-09-16
HTF Curette General, Plastic Surgery Class 1 878.4800 1992-12-14
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2012-07-03
GAD Retractor General, Plastic Surgery Class 1 878.4800 2003-09-16
IRQ Unit, Heating, Powered Physical Medicine Class 1 890.5950 2009-06-09
JEY Plate, Bone Dental Class 2 872.4760 2013-02-25
NEI Prosthesis, Condyle, Mandibular, Temporary Dental Class 2 872.4770 2009-06-19
PUI Drape, Surgical, Exempt General, Plastic Surgery Class 2 878.4370 2018-07-12
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-05-04
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2023-05-04
GXP Methyl Methacrylate For Cranioplasty Neurology Class 2 882.5300 2007-02-05
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2024-03-21
JDQ Cerclage, Fixation Orthopedic Class 2 888.3010 2024-03-21
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-03-21
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2024-09-20
FMA Depressor, Tongue, Non-Surgical General Hospital Class 1 880.6230 2003-09-16
KAN Chisel, Nasal General, Plastic Surgery Class 1 878.4800 2003-09-16
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-09-20
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-09-20
MQN External Mandibular Fixator And/Or Distractor Dental Class 2 872.4760 2012-07-03
FWZ Operating Room Accessories Table Tray General, Plastic Surgery Class 1 878.4950 2018-07-06
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 1998-08-14
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2003-09-16
EIX Probe, Periodontic Dental Class 1 872.4565 2012-12-17
FNY Basin, Emesis General Hospital Class 1 880.6730 1992-12-14
JYG Curette, Ear Ear, Nose, Throat Class 1 874.4420 2003-10-16
EIL Gauge, Depth, Instrument, Dental Dental Class 1 872.4565 2003-09-16
KAE Forceps, Ent Ear, Nose, Throat Class 1 874.4420 2003-09-16
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2015-11-12
GAF Spatula, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2003-09-16
FRG Wrap, Sterilization General Hospital Class 2 880.6850 2016-05-05
EMJ Elevator, Surgical, Dental Dental Class 1 872.4565 2003-09-16
KAT Perforator, Antrum Ear, Nose, Throat Class 1 874.4420 2003-09-16
EKI Carrier, Amalgam, Operative Dental Class 1 872.4565 2003-09-16
KAL Retractor, Ent Ear, Nose, Throat Class 1 874.4420 2012-02-27
HWI Corkscrew Orthopedic Class 1 888.4540 2012-05-16
GFJ Mallet, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2003-09-16
EMI File, Bone, Surgical Dental Class 1 872.4565 2003-09-16
GEA Cannula, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2003-09-16
DZJ Driver, Wire, And Bone Drill, Manual Dental Class 2 872.4120 2015-03-25
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2015-03-25
JEY Plate, Bone Dental Class 2 872.4760 2015-03-25
GEY Motor, Surgical Instrument, Ac-Powered General, Plastic Surgery Class 1 878.4820 2003-10-16
JEY Plate, Bone Dental Class 2 872.4760 2012-05-11
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 1998-08-14
KBD Scissors, Nasal Ear, Nose, Throat Class 1 874.4420 2003-09-16
HTW Bit, Drill Orthopedic Class 1 888.4540 2003-09-16
JEY Plate, Bone Dental Class 2 872.4760 1992-12-14
JEY Plate, Bone Dental Class 2 872.4760 2015-04-02
DZL Screw, Fixation, Intraosseous Dental Class 2 872.4880 2015-04-02
EKB Explorer, Operative Dental Class 1 872.4565 2003-09-16
HXI Passer, Wire, Orthopedic Orthopedic Class 1 888.4540 2003-09-16
KBM Dissector, Tonsil Ear, Nose, Throat Class 1 874.4420 2003-09-16
GES Blade, Scalpel General, Plastic Surgery Class 1 878.4800 2003-09-16
FTY Tape, Measuring, Rulers And Calipers General, Plastic Surgery Class 1 878.4800 2003-09-16
KAS Knife, Nasal Ear, Nose, Throat Class 1 874.4420 2003-09-16
GXP Methyl Methacrylate For Cranioplasty Neurology Class 2 882.5300 2007-02-05
GDI Dissector, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2003-09-16
ECB Unit, Syringe, Air And/Or Water Dental Class 1 872.4565 2014-11-04
HRX Arthroscope Orthopedic Class 2 888.1100 2012-08-30
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2012-08-30
LZK Implant, Malar General, Plastic Surgery Class 2 878.3550 2009-12-17
KKY Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction General, Plastic Surgery Class 2 878.3500 2009-12-17
FZE Prosthesis, Nose, Internal General, Plastic Surgery Class 2 878.3680 2009-12-17
FWP Prosthesis, Chin, Internal General, Plastic Surgery Class 2 878.3550 2009-12-17
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2024-08-22
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2024-08-22
HWT Template Orthopedic Class 1 888.4800 2011-09-09
LWF Dilator, Nasal Ear, Nose, Throat Class 1 874.3900 2003-09-16

Official Correspondent

Stephanie Schrauder

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BIOMET MICROFIXATION
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
K172572 Stryker Stryker Upper-Face AXS screws and Mid-Face AXS screws 2017-10-31
K121589 Biomet Microfixation BIOMET MICROFIXATION FACIAL PLATING SYSTEM 2012-09-21
K984230 Osteogenics Biomedical, Inc. OSTEO-MESH TM-300 1999-02-04
K021618 Osteomed Corp. OSA RIGID INTERNAL FIXATION SYSTEM 2002-08-08
K852723 The Huxley Instrument Corp. FOERSTER SPONGE FORCEPS, SERRATED, 7+SS 410 OR 420 1985-07-15

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0012-2012 Biomet Microfixation, Inc. 1
Biomet Microfixation outer packaging labeled in part:"REF: SP-2411***RUBBER BAND, LATEX FREE SMALL, HEAVY, 300/PACKAGE 4MM, (3/16" INNER DIAMETER) NON LATEX ELASTICS LOT 307850***DISTRIBUTED BY: BIOMET MICROFIXATION 1520 Tradeport Drive, Jacksonville, FL 32218 USA www.biometmicrofixation.com***." Inner Vendor/Manufacturer Label labeled in part:"H4 Elastics 4mm (3/16") Heavy 4 oz. REF 11-102-04***Manufactured for DENTSPLY GAC INTERNATIONAL DENTSPLY INTERNATIONAL, INC. Phone 631-419-1700 Fax 631-419-1599 355 Knickerbocker Avenue Bohemia NY 11716 USA***MediMark Europe BP2332 F-38033 Grenoble Cedex 2. France***LOT 82936-32 QTY:100 pk use by 2012-07 Made in USA ISSUED DATE 2009-04 GN***" Elastic bands used as elastomeric ties for ligation that facilitate treatment of fracture of the mandible and maxilla. They are commonly used with braces or arch bar wire.
Z-0043-2007 Bioplate Inc 2
Bioplate Resorbable Bone Fixation Tack, Catalog Number: 89-0120, Item Number: SG#-45
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1032347. Last updated year: 2026. Please use registration number 1032347 when referencing this establishment in official correspondence.
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