Medical Device Manufacturer · US , Jacksonville , FL

Biomet Microfixation

24 submissions · 24 cleared · Since 2012
24
Total
24
Cleared
0
Denied

Biomet Microfixation — FDA 510(k) Submissions

Biomet Microfixation has submitted 24 FDA 510(k) premarket notifications since 2012, of which 24 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Plate, Fixation, Bone, Plate, Bone, Drills, Burrs, Trephines & Accessories (simple, Powered), Plate, Cranioplasty, Preformed, Alterable, Cover, Burr Hole . Use the specialty filter in the sidebar to narrow results.

24 devices
1–24 of 24
Pectus Blu Support Bar System
K241709 · HRS Plate, Fixation, Bone · Orthopedic
Sep 2024 98d
2.1 x 255mm Drill, 22mm Stop
K223199 · HBE Drills, Burrs, Trephines... · Neurology
Nov 2022 33d
SternaLock Sternal Closure System
K212782 · HRS Plate, Fixation, Bone · Orthopedic
May 2022 258d
RibFix Blu Thoracic Fixation System
K212608 · HRS Plate, Fixation, Bone · Orthopedic
Apr 2022 248d
Pectus Support Bar System
K213712 · HRS Plate, Fixation, Bone · Orthopedic
Mar 2022 107d
Twist Drills
K213208 · HBE Drills, Burrs, Trephines... · Neurology
Dec 2021 85d
Biomet Microfixation OmniMax MMF System
K202969 · JEY Plate, Bone · Dental
Aug 2021 309d
WalterLorenz Surgical Assist Arm Scope Holder
K190576 · OCV Endoscope Holder · General & Plastic Surgery
Jun 2019 91d
Biomet Microfixation RibFix Blu Thoracic Fixation System
K162974 · HRS Plate, Fixation, Bone · Orthopedic
Dec 2016 45d
Biomet Microfixation SternaLock 360 Sternal Closure System
K163007 · HRS Plate, Fixation, Bone · Orthopedic
Nov 2016 26d
Biomet Microfixation Sternal Closure System
K161896 · HRS Plate, Fixation, Bone · Orthopedic
Aug 2016 22d
Biomet Microfixation RibFix Blu Thoracic Fixation System
K152253 · HRS Plate, Fixation, Bone · Orthopedic
Mar 2016 227d
Biomet Microfixation OmniMax MMF System
K152326 · JEY Plate, Bone · Dental
Dec 2015 114d
SternaLock? 360 Sternal Closure System
K151019 · HRS Plate, Fixation, Bone · Orthopedic
Nov 2015 201d
Biomet Microfixation RibFix Blu Thoracic Fixation System
K151173 · HWC Screw, Fixation, Bone · Orthopedic
May 2015 25d
Biomet Microfixation OmniMax MMF System
K143336 · JEY Plate, Bone · Dental
Apr 2015 132d
Biomet Microfixation Thoracic Fixation System
K142823 · HRS Plate, Fixation, Bone · Orthopedic
Feb 2015 148d
FACIAL PREBENT PLATING WITH VIRTUAL SURGICAL PLANNING
K132600 · JEY Plate, Bone · Dental
Oct 2013 43d
PREBENT PLATING WITH VIRTUAL SURGICAL PLANNING
K131674 · JEY Plate, Bone · Dental
Aug 2013 62d
RAPIDFLAP LS CRANIAL FLAP FIXATION SYSTEM
K130309 · GXR Cover, Burr Hole · Neurology
Jun 2013 130d
BIOMET MICROFIXATION NEURO PLATING SYSTEM
K121624 · GWO Plate, Cranioplasty,... · Neurology
Oct 2012 133d
BIOMET MICROFIXATION FACIAL PLATING SYSTEM
K121589 · JEY Plate, Bone · Dental
Sep 2012 113d
BIOMET MICROFIXATION STERNAL CLOSURE SYSTEM
K121302 · HRS Plate, Fixation, Bone · Orthopedic
Sep 2012 141d
BIOMET MICROFIXATION MANDIBULAR FRACTURE/ RECONSTRUCTION DEVICES AND PREBENT PLATES SYSTEM
K113512 · JEY Plate, Bone · Dental
Jun 2012 214d
Filters