FDA Registration Active 🇺🇸 United States

BIOMET MICROFIXATION

Reg #: 1032347 · FEI: 1032347 · Expires 2026
Products
150
Proprietary Names
256
Establishment Types
4
Classifications
150

Registration Details

Registration Name
BIOMET MICROFIXATION
Registration Number
1032347
FEI Number
1032347
Status
Active
Expiry Year
2026
Initial Importer
No
Address
1520 Tradeport Dr
City
Jacksonville
State
FL
ZIP
32218
Country
US

Regulatory Submissions

510(k) Number
K910038
PMA Number
P020016

Owner / Operator

Firm Name
BIOMET MICROFIXATION
Operator Number
1032347
Address
1520 TRADEPORT DR., --
City
Jacksonville
State
FL
Postal Code
32218
Country
US
Correspondent
Stephanie Schrauder

Products

Device Name Product Code
Holder, Needle; Orthopedic HXK
Plate, Bone JEY
Forceps HTD
Drills, Burrs, Trephines & Accessories (Simple, Powered) HBE
Depressor, Metal Tongue, Surgical KBL
Screw, Fixation, Bone HWC
Plate, Fixation, Bone HRS
Joint, Temporomandibular, Implant LZD
Setter, Band, Orthodontic ECR
Articulators EJP
Headlamp, Operating, Battery-Operated HPP
Wrench HXC
Gouge, Surgical, General & Plastic Surgery GDH
Blade, Saw, General & Plastic Surgery, Surgical GFA
Caliper KTZ
Guide, Surgical, Instrument FZX
Pusher, Band, Orthodontic ECS
Stripper, Surgical HRT
Forceps, General & Plastic Surgery GEN
Expander, Surgical, Skin Graft FZW
Fastener, Plate, Cranioplasty HBW
Cover, Burr Hole GXR
Plate, Cranioplasty, Preformed, Alterable GWO
Driver, Wire, And Bone Drill, Manual DZJ
System, Image Processing, Radiological LLZ
Drape, Surgical, Antimicrobial KKX
Band, Elastic, Orthodontic ECI
Retractor, All Types EIG
Source, Carrier, Fiberoptic Light EQH
Cutter, Surgical FZT
Twister, Wire HXS
Elevator, Ent KAD
Brush, Scrub, Operating-Room GEC
Rongeur HTX
Instruments, Dental Hand DZN
Extractor HWB
Electrosurgical, Cutting & Coagulation & Accessories GEI
Tray, Surgical LRP
Bender HXW
Pin, Fixation, Smooth HTY
External Mandibular Fixator And/Or Distractor MQN
Gag, Mouth KBN
Speculum, Ent EPY
Mirror, Mouth EAX
Screwdriver, Skullplate GXL
Bur, Ear, Nose And Throat EQJ
Cutter, Wire HXZ
Wire, Orthodontic DZC
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories KCT
Forceps, Ophthalmic HNR
Tray, Surgical, Instrument FSM
Bone Mill LYS
Rasp, Surgical, General & Plastic Surgery GAC
Kit, Surgical Instrument, Disposable KDD
Orthopedic Manual Surgical Instrument LXH
Instrument, Manual, Surgical, General Use MDM
Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control DBL
Splint, Extremity, Non-Inflatable, External, Non-Sterile NOC
Probe, Lachrymal HNL
Washer, Bolt Nut HTN
Scissors, General, Surgical LRW
Accessories, Retractor, Dental EIF
Implant, Endosseous, Root-Form DZE
Scissors, Surgical Tissue, Dental EGN
Chisel, Bone, Surgical EML
Curette, Nasal KAP
Laparoscope, General & Plastic Surgery GCJ
Endoscope Holder OCV
Instrument, Ligature Tucking, Orthodontic ECP
Rasp, Nasal KBA
Guide, Needle, Surgical GDF
Pack, Hot Or Cold, Disposable IMD
Forceps, Tooth Extractor, Surgical EMG
Tamp HXG
Screw, Fixation, Intraosseous DZL
Plate, Cranioplasty, Preformed, Non-Alterable GXN
Tap, Bone HWX
Curette HTF
Retractor GAD
Unit, Heating, Powered IRQ
Prosthesis, Condyle, Mandibular, Temporary NEI
Drape, Surgical, Exempt PUI
Methyl Methacrylate For Cranioplasty GXP
Cerclage, Fixation JDQ
Depressor, Tongue, Non-Surgical FMA
Chisel, Nasal KAN
Operating Room Accessories Table Tray FWZ
Probe, Periodontic EIX
Basin, Emesis FNY
Curette, Ear JYG
Gauge, Depth, Instrument, Dental EIL
Forceps, Ent KAE
Spatula, Surgical, General & Plastic Surgery GAF
Wrap, Sterilization FRG
Elevator, Surgical, Dental EMJ
Perforator, Antrum KAT
Carrier, Amalgam, Operative EKI
Retractor, Ent KAL
Corkscrew HWI
Mallet, Surgical, General & Plastic Surgery GFJ
File, Bone, Surgical EMI
Cannula, Surgical, General & Plastic Surgery GEA
Motor, Surgical Instrument, Ac-Powered GEY
Scissors, Nasal KBD
Bit, Drill HTW
Explorer, Operative EKB
Passer, Wire, Orthopedic HXI
Dissector, Tonsil KBM
Blade, Scalpel GES
Tape, Measuring, Rulers And Calipers FTY
Knife, Nasal KAS
Dissector, Surgical, General & Plastic Surgery GDI
Unit, Syringe, Air And/Or Water ECB
Arthroscope HRX
Implant, Malar LZK
Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction KKY
Prosthesis, Nose, Internal FZE
Prosthesis, Chin, Internal FWP
Template HWT
Dilator, Nasal LWF
Hook, Surgical, General & Plastic Surgery GDG
Prosthesis, Larynx (Stents And Keels) FWN
Apparatus, Suction, Operating-Room, Wall Vacuum Powered GCX
Retractor, Ophthalmic HNI
Cement, Ear, Nose And Throat NEA
Osteotome HWM
Chisel, Osteotome, Surgical EMM
Syringe, Periodontic, Endodontic, Irrigating EIC
Scissors, Ophthalmic HNF
Handle, Scalpel GDZ
Forceps, Dressing, Dental EFL
Filler, Bone Void, Calcium Compound MQV
Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) MBP
Chisel, Surgical, Manual FZO
Probe HXB
Clamp, Surgical, General & Plastic Surgery GDJ
Clamp, Vascular DXC
Screwdriver HXX
Rongeur, Nasal KBB
Handle, Instrument, Dental EJB
Container, Liquid Medication, Graduated KYW
Pliers, Surgical HTC
Knife, Ent KTG
Elevator, Surgical, General & Plastic Surgery GEG
Implant, Endosseous, Orthodontic OAT
Trephine HWK
Awl HWJ
Forceps, Rongeur, Surgical EMH
Gouge, Nasal, Ent KAQ
Trocar, Ent KTE

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 RibFix Advantage Articulator Biomet Microfixation Sternalock 2mm 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 Adson Forceps Expander 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 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 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 Aesculap SterilContainer Micro Forceps Adkins Strut 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 Biomet Microfixation Thoracic Fixation System Scissors Face Lift Scissors Micro Scissors QC Removal Tool Mouth Prop VENAPAX XL Self Drilling IMF Screw Pectus Blu System Bi Phase Palate Scissors Osteotome Chisel CURETTE Walter Scope Holder WalterLorenz Surgical Assist Arm Scope Holder Gauze Director Ligature Tucker Nasal Rasp Diamond Rasp Needle Guide LactoSorb Heat Pack Extracting Forceps Bone Tamp Twist Drill OmniMax Spindown Rapidflap Tap Lactosorb Water Bath Add on Condyle WalterLorenz Surgical Assist Arm Walter Drape with Button RibFix Blu Thoracic Fixation System MIMIX QS MIMIX QUICK SET Pectus Blu Support Bar System Pectus Blu TruLink Tongue Depressor Lorenz Distraction System Pectus Bar System Self Drilling Screw Periodontal Probe Basin Curette Dental Gauge Ear Forceps Septum Forceps SternaLock 360 Sternal Closure System SternaLock 360 SL 360 Spatula Aesculap SterilContainer System Dental Elevator Periosteal Elevator Perforator Carrier Byrd Screw Hammer Mallet Bone File Cannula POWER DRIVER iQ Intelligent Driver Pectus Bar Stabilizer Nasal Scissors Septum Scissors Fracture/Reconstruction Plating 2.3mm System OmniMax MMF System Explorer Wire Passer Dissector Scalpel Blade Button Knife Nasal Knife Knife MIMIX 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 Hook Skin Hook Nerve Hook Bone Hook Zygoma Hook IMF System OmniMax MMF Cotton Lorenz Prosthesis Yankauer, Andrews-Pynchon, Lorenz, Wallace, Holz, Frazier Coupland, etc. SternaLock Sternal Closure System Orbital Retractor OTOMIMIX PreBent Pectus Bar System Aspirating Syringe Aquafix Syringe Syringe iris Pre-Bent Plate Scalpel Handle Towel Forceps Dressing Forceps Allogenix Bone Chisel Probe TraumaOne System Micro Clamp Ramus Clamp Clamp TMJ Clamp Pectus Clamp Vascular Clamp Blade Screwdriver Morselizer Handle Container Pliers Cotton Pliers Bone Bending Pliers Wire Cutting Pliers Plate Bending Pliers RapidFire ORTHODONTIC ANCHORAGE SYSTEM Trephine Biomet Microfixation Sternal Closure System Mandible Awl Maxillary Awl Awl Zygomatic Awl JACE Medical Thoracic Plating System Bone Cutting Forceps Nasal Gouge Trocar 2.4mm Trocar LactoSorb Trocar 2.7mm Trocar Bi-Phase Trocar 2mm Trocar TraumaOne Trocar

Establishment Types

Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198