Biomet Microfixation is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Biomet Microfixation - FDA 510(k) Cleared Devices
Recent clearances: Pectus Blu System, Pectus Blu Support Bar System, 2.1 x 255mm Drill, 22mm Stop
25
Total
25
Cleared
0
Denied
Biomet Microfixation has 25 FDA 510(k) cleared medical devices. Based in Jacksonville, US.
Latest FDA clearance: Jun 2026. Active since 2012. Primary specialty: Orthopedic.
Browse the FDA 510(k) cleared devices submitted by Biomet Microfixation Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by MRC Global, LLC and MRC Global.
FDA 510(k) Regulatory Record - Biomet Microfixation
25 devices
Cleared
Jun 02, 2026
Pectus Blu System
Orthopedic
68d
Cleared
Sep 19, 2024
Pectus Blu Support Bar System
Orthopedic
98d
Cleared
Nov 15, 2022
2.1 x 255mm Drill, 22mm Stop
Neurology
33d
Cleared
May 17, 2022
SternaLock Sternal Closure System
Orthopedic
258d
Cleared
Apr 22, 2022
RibFix Blu Thoracic Fixation System
Orthopedic
248d
Cleared
Mar 11, 2022
Pectus Support Bar System
Orthopedic
107d
Cleared
Dec 23, 2021
Twist Drills
Neurology
85d
Cleared
Aug 05, 2021
Biomet Microfixation OmniMax MMF System
Dental
309d
Cleared
Jun 05, 2019
WalterLorenz Surgical Assist Arm Scope Holder
General & Plastic Surgery
91d
Cleared
Dec 09, 2016
Biomet Microfixation RibFix Blu Thoracic Fixation System
Orthopedic
45d
Cleared
Nov 23, 2016
Biomet Microfixation SternaLock 360 Sternal Closure System
Orthopedic
26d
Cleared
Aug 02, 2016
Biomet Microfixation Sternal Closure System
Orthopedic
22d
Cleared
Mar 24, 2016
Biomet Microfixation RibFix Blu Thoracic Fixation System
Orthopedic
227d
Cleared
Dec 10, 2015
Biomet Microfixation OmniMax MMF System
Dental
114d
Cleared
Nov 03, 2015
SternaLock® 360 Sternal Closure System
Orthopedic
201d
Cleared
May 26, 2015
Biomet Microfixation RibFix Blu Thoracic Fixation System
Orthopedic
25d
Cleared
Apr 01, 2015
Biomet Microfixation OmniMax MMF System
Dental
132d
Cleared
Feb 25, 2015
Biomet Microfixation Thoracic Fixation System
Orthopedic
148d
Cleared
Oct 02, 2013
FACIAL PREBENT PLATING WITH VIRTUAL SURGICAL PLANNING
Dental
43d
Cleared
Aug 08, 2013
PREBENT PLATING WITH VIRTUAL SURGICAL PLANNING
Dental
62d
Cleared
Jun 17, 2013
RAPIDFLAP LS CRANIAL FLAP FIXATION SYSTEM
Neurology
130d
Cleared
Oct 12, 2012
BIOMET MICROFIXATION NEURO PLATING SYSTEM
Neurology
133d
Cleared
Sep 21, 2012
BIOMET MICROFIXATION FACIAL PLATING SYSTEM
Dental
113d
Cleared
Sep 19, 2012
BIOMET MICROFIXATION STERNAL CLOSURE SYSTEM
Orthopedic
141d
Cleared
Jun 29, 2012
BIOMET MICROFIXATION MANDIBULAR FRACTURE/ RECONSTRUCTION DEVICES AND PREBENT...
Dental
214d