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 | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Holder, Needle; Orthopedic | HXK | Class 1 | Orthopedic | No | 2003-09-16 |
| Plate, Bone | JEY | Class 2 | Dental | No | 2012-05-11 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 1992-12-14 |
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | HBE | Class 2 | Neurology | No | 2023-04-19 |
| Depressor, Metal Tongue, Surgical | KBL | Class 1 | Ear, Nose, Throat | No | 2019-07-17 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2003-09-16 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2017-05-17 |
| Joint, Temporomandibular, Implant | LZD | Class 3 | Dental | No | 2007-12-04 |
| Setter, Band, Orthodontic | ECR | Class 1 | Dental | No | 2021-02-02 |
| Articulators | EJP | Class 1 | Dental | No | 1992-12-14 |
| Headlamp, Operating, Battery-Operated | HPP | Class 1 | Ophthalmic | No | 2016-02-05 |
| Wrench | HXC | Class 1 | Orthopedic | No | 2001-04-20 |
| Gouge, Surgical, General & Plastic Surgery | GDH | Class 1 | General, Plastic Surgery | No | 1992-12-14 |
| Blade, Saw, General & Plastic Surgery, Surgical | GFA | Class 1 | General, Plastic Surgery | No | 2003-09-16 |
| Caliper | KTZ | Class 1 | Orthopedic | No | 2021-02-02 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2003-09-16 |
| Pusher, Band, Orthodontic | ECS | Class 1 | Dental | No | 2003-09-16 |
| Stripper, Surgical | HRT | Class 1 | Orthopedic | No | 2003-09-16 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 2003-09-16 |
| Expander, Surgical, Skin Graft | FZW | Class 1 | General, Plastic Surgery | No | 2003-09-16 |
| Fastener, Plate, Cranioplasty | HBW | Class 2 | Neurology | No | 2013-02-08 |
| Cover, Burr Hole | GXR | Class 2 | Neurology | No | 2013-02-08 |
| Plate, Cranioplasty, Preformed, Alterable | GWO | Class 2 | Neurology | No | 2013-02-08 |
| Driver, Wire, And Bone Drill, Manual | DZJ | Class 2 | Dental | No | 2015-03-25 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2015-03-25 |
| Drape, Surgical, Antimicrobial | KKX | Class 2 | General, Plastic Surgery | No | 2012-06-04 |
| Band, Elastic, Orthodontic | ECI | Class 1 | Dental | No | 2010-11-29 |
| Retractor, All Types | EIG | Class 1 | Dental | No | 2003-09-16 |
| Source, Carrier, Fiberoptic Light | EQH | Class 1 | Ear, Nose, Throat | No | 2003-09-16 |
| Cutter, Surgical | FZT | Class 1 | General, Plastic Surgery | No | 2003-09-16 |
| Twister, Wire | HXS | Class 1 | Orthopedic | No | 2003-09-16 |
| Elevator, Ent | KAD | Class 1 | Ear, Nose, Throat | No | 2003-09-16 |
| Brush, Scrub, Operating-Room | GEC | Class 1 | General, Plastic Surgery | No | 2011-01-21 |
| Rongeur | HTX | Class 1 | Orthopedic | No | 2012-12-19 |
| Instruments, Dental Hand | DZN | Class 1 | Dental | No | 2012-12-17 |
| Extractor | HWB | Class 1 | Orthopedic | No | 2012-02-27 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2012-12-17 |
| Tray, Surgical | LRP | Class 1 | General, Plastic Surgery | No | 2003-10-16 |
| Bender | HXW | Class 1 | Orthopedic | No | 2008-09-18 |
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2013-01-21 |
| External Mandibular Fixator And/Or Distractor | MQN | Class 2 | Dental | No | 2013-01-30 |
| Gag, Mouth | KBN | Class 1 | Ear, Nose, Throat | No | 2003-09-16 |
| Speculum, Ent | EPY | Class 1 | General, Plastic Surgery | No | 2003-09-16 |
| Mirror, Mouth | EAX | Class 1 | Dental | No | 2003-09-16 |
| Screwdriver, Skullplate | GXL | Class 1 | Neurology | No | 2023-07-06 |
| Bur, Ear, Nose And Throat | EQJ | Class 1 | Ear, Nose, Throat | No | 2003-09-16 |
| Cutter, Wire | HXZ | Class 1 | Orthopedic | No | 2003-09-16 |
| Wire, Orthodontic | DZC | Class 1 | Dental | No | 2003-09-16 |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | Class 2 | General Hospital | No | 2016-05-05 |
| Forceps, Ophthalmic | HNR | Class 1 | Ophthalmic | No | 2012-03-02 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2003-09-16 |
| Bone Mill | LYS | Class 1 | Orthopedic | No | 2003-09-16 |
| Rasp, Surgical, General & Plastic Surgery | GAC | Class 1 | General, Plastic Surgery | No | 2003-09-16 |
| Kit, Surgical Instrument, Disposable | KDD | Class 1 | General, Plastic Surgery | No | 2008-01-08 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2004-12-10 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2011-01-25 |
| Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control | DBL | Class 2 | Immunology | No | 2008-04-07 |
| Splint, Extremity, Non-Inflatable, External, Non-Sterile | NOC | Class 1 | General, Plastic Surgery | No | 2016-11-11 |
| Probe, Lachrymal | HNL | Class 1 | Ophthalmic | No | 2003-09-16 |
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2021-06-18 |
| Scissors, General, Surgical | LRW | Class 1 | General, Plastic Surgery | No | 2003-09-16 |
| Accessories, Retractor, Dental | EIF | Class 1 | Dental | No | 2003-09-16 |
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2012-05-16 |
| Scissors, Surgical Tissue, Dental | EGN | Class 1 | Dental | No | 2003-09-16 |
| Chisel, Bone, Surgical | EML | Class 1 | Dental | No | 2003-09-16 |
| Curette, Nasal | KAP | Class 1 | Ear, Nose, Throat | No | 2003-09-16 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2019-06-11 |
| Endoscope Holder | OCV | Class 2 | Gastroenterology, Urology | No | 2019-06-11 |
| Instrument, Ligature Tucking, Orthodontic | ECP | Class 1 | Dental | No | 2003-09-16 |
| Rasp, Nasal | KBA | Class 1 | Ear, Nose, Throat | No | 2003-09-16 |
| Guide, Needle, Surgical | GDF | Class 1 | General, Plastic Surgery | No | 2003-09-16 |
| Pack, Hot Or Cold, Disposable | IMD | Class 1 | Physical Medicine | No | 2012-06-04 |
| Forceps, Tooth Extractor, Surgical | EMG | Class 1 | Dental | No | 2003-09-16 |
| Tamp | HXG | Class 1 | Orthopedic | No | 2012-12-17 |
| Screw, Fixation, Intraosseous | DZL | Class 2 | Dental | No | 2021-09-24 |
| Plate, Cranioplasty, Preformed, Non-Alterable | GXN | Class 2 | Neurology | No | 2009-12-17 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2003-09-16 |
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 1992-12-14 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2003-09-16 |
| Unit, Heating, Powered | IRQ | Class 1 | Physical Medicine | No | 2009-06-09 |
| Prosthesis, Condyle, Mandibular, Temporary | NEI | Class 2 | Dental | No | 2009-06-19 |
| Drape, Surgical, Exempt | PUI | Class 2 | General, Plastic Surgery | No | 2018-07-12 |
| Methyl Methacrylate For Cranioplasty | GXP | Class 2 | Neurology | No | 2007-02-05 |
| Cerclage, Fixation | JDQ | Class 2 | Orthopedic | No | 2024-03-21 |
| Depressor, Tongue, Non-Surgical | FMA | Class 1 | General Hospital | No | 2003-09-16 |
| Chisel, Nasal | KAN | Class 1 | General, Plastic Surgery | No | 2003-09-16 |
| Operating Room Accessories Table Tray | FWZ | Class 1 | General, Plastic Surgery | No | 2018-07-06 |
| Probe, Periodontic | EIX | Class 1 | Dental | No | 2012-12-17 |
| Basin, Emesis | FNY | Class 1 | General Hospital | No | 1992-12-14 |
| Curette, Ear | JYG | Class 1 | Ear, Nose, Throat | No | 2003-10-16 |
| Gauge, Depth, Instrument, Dental | EIL | Class 1 | Dental | No | 2003-09-16 |
| Forceps, Ent | KAE | Class 1 | Ear, Nose, Throat | No | 2003-09-16 |
| Spatula, Surgical, General & Plastic Surgery | GAF | Class 1 | General, Plastic Surgery | No | 2003-09-16 |
| Wrap, Sterilization | FRG | Class 2 | General Hospital | No | 2016-05-05 |
| Elevator, Surgical, Dental | EMJ | Class 1 | Dental | No | 2003-09-16 |
| Perforator, Antrum | KAT | Class 1 | Ear, Nose, Throat | No | 2003-09-16 |
| Carrier, Amalgam, Operative | EKI | Class 1 | Dental | No | 2003-09-16 |
| Retractor, Ent | KAL | Class 1 | Ear, Nose, Throat | No | 2012-02-27 |
| Corkscrew | HWI | Class 1 | Orthopedic | No | 2012-05-16 |
| Mallet, Surgical, General & Plastic Surgery | GFJ | Class 1 | General, Plastic Surgery | No | 2003-09-16 |
| File, Bone, Surgical | EMI | Class 1 | Dental | No | 2003-09-16 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 2003-09-16 |
| Motor, Surgical Instrument, Ac-Powered | GEY | Class 1 | General, Plastic Surgery | No | 2003-10-16 |
| Scissors, Nasal | KBD | Class 1 | Ear, Nose, Throat | No | 2003-09-16 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2003-09-16 |
| Explorer, Operative | EKB | Class 1 | Dental | No | 2003-09-16 |
| Passer, Wire, Orthopedic | HXI | Class 1 | Orthopedic | No | 2003-09-16 |
| Dissector, Tonsil | KBM | Class 1 | Ear, Nose, Throat | No | 2003-09-16 |
| Blade, Scalpel | GES | Class 1 | General, Plastic Surgery | No | 2003-09-16 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2003-09-16 |
| Knife, Nasal | KAS | Class 1 | Ear, Nose, Throat | No | 2003-09-16 |
| Dissector, Surgical, General & Plastic Surgery | GDI | Class 1 | General, Plastic Surgery | No | 2003-09-16 |
| Unit, Syringe, Air And/Or Water | ECB | Class 1 | Dental | No | 2014-11-04 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2012-08-30 |
| Implant, Malar | LZK | Class 2 | General, Plastic Surgery | No | 2009-12-17 |
| Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction | KKY | Class 2 | General, Plastic Surgery | No | 2009-12-17 |
| Prosthesis, Nose, Internal | FZE | Class 2 | General, Plastic Surgery | No | 2009-12-17 |
| Prosthesis, Chin, Internal | FWP | Class 2 | General, Plastic Surgery | No | 2009-12-17 |
| Template | HWT | Class 1 | Orthopedic | No | 2011-09-09 |
| Dilator, Nasal | LWF | Class 1 | Ear, Nose, Throat | No | 2003-09-16 |
| Hook, Surgical, General & Plastic Surgery | GDG | Class 1 | General, Plastic Surgery | No | 2003-09-16 |
| Prosthesis, Larynx (Stents And Keels) | FWN | Class 2 | Ear, Nose, Throat | No | 2009-12-17 |
| Apparatus, Suction, Operating-Room, Wall Vacuum Powered | GCX | Class 2 | General Hospital | No | 2012-02-27 |
| Retractor, Ophthalmic | HNI | Class 1 | Ophthalmic | No | 2009-12-17 |
| Cement, Ear, Nose And Throat | NEA | Class 2 | Dental | No | 2004-11-23 |
| Osteotome | HWM | Class 1 | General, Plastic Surgery | No | 2003-09-16 |
| Chisel, Osteotome, Surgical | EMM | Class 1 | Dental | No | 2003-09-16 |
| Syringe, Periodontic, Endodontic, Irrigating | EIC | Class 1 | Dental | No | 2003-09-16 |
| Scissors, Ophthalmic | HNF | Class 1 | Ophthalmic | No | 2012-02-27 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 2003-09-16 |
| Forceps, Dressing, Dental | EFL | Class 1 | Dental | No | 2003-09-16 |
| Filler, Bone Void, Calcium Compound | MQV | Class 2 | Orthopedic | No | 2022-04-04 |
| Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) | MBP | Class 2 | Orthopedic | No | 2022-04-04 |
| Chisel, Surgical, Manual | FZO | Class 1 | General, Plastic Surgery | No | 1992-12-14 |
| Probe | HXB | Class 1 | Orthopedic | No | 2012-02-27 |
| Clamp, Surgical, General & Plastic Surgery | GDJ | Class 1 | General, Plastic Surgery | No | 2003-09-16 |
| Clamp, Vascular | DXC | Class 2 | Cardiovascular | No | 2009-12-18 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2003-09-16 |
| Rongeur, Nasal | KBB | Class 1 | Ear, Nose, Throat | No | 2003-09-16 |
| Handle, Instrument, Dental | EJB | Class 1 | Dental | No | 2003-09-16 |
| Container, Liquid Medication, Graduated | KYW | Class 1 | General Hospital | No | 2011-01-21 |
| Pliers, Surgical | HTC | Class 1 | General, Plastic Surgery | No | 2003-09-16 |
| Knife, Ent | KTG | Class 1 | Ear, Nose, Throat | No | 2003-09-16 |
| Elevator, Surgical, General & Plastic Surgery | GEG | Class 1 | General, Plastic Surgery | No | 2003-09-16 |
| Implant, Endosseous, Orthodontic | OAT | Class 2 | Dental | No | 2007-02-21 |
| Trephine | HWK | Class 1 | Orthopedic | No | 2009-12-17 |
| Awl | HWJ | Class 1 | Orthopedic | No | 1992-12-14 |
| Forceps, Rongeur, Surgical | EMH | Class 1 | Dental | No | 2003-09-16 |
| Gouge, Nasal, Ent | KAQ | Class 1 | Ear, Nose, Throat | No | 2003-09-16 |
| Trocar, Ent | KTE | Class 1 | Ear, Nose, Throat | No | 2003-09-16 |
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