Medical Device Manufacturer · US , Addison , TX

Osteomed

12 submissions · 12 cleared · Since 2012
12
Total
12
Cleared
0
Denied

Osteomed — FDA 510(k) Submissions

Osteomed has submitted 12 FDA 510(k) premarket notifications since 2012, of which 12 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Plate, Fixation, Bone, Screw, Fixation, Bone, Screw, Fixation, Intraosseous, Drills, Burrs, Trephines & Accessories (simple, Powered), Handpiece, Rotary Bone Cutting . Use the specialty filter in the sidebar to narrow results.

12 devices
1–12 of 12
ExtremiLOCK Lateral Ankle Fusion Plates
K203479 · HRS Plate, Fixation, Bone · Orthopedic
Feb 2021 89d
OsteoMed PINNACLE Driver
K162542 · HBE Drills, Burrs, Trephines... · Neurology
May 2017 249d
OsteoMed PINNACLE Driver
K162544 · KMW Handpiece, Rotary Bone... · Dental
Apr 2017 204d
OsteoMed ExtremiLOCK Wrist Plating System
K161041 · HRS Plate, Fixation, Bone · Orthopedic
May 2016 36d
OsteoMed ExtremiLOCK Wrist Plating System
K152145 · HRS Plate, Fixation, Bone · Orthopedic
Dec 2015 140d
OsteoMed IMF Screw
K151195 · DZL Screw, Fixation,... · Dental
Sep 2015 140d
OSTEOMED LOW PROFILE ORBITAL FLOOR PLATE SYSTEM
K140978 · JEY Plate, Bone · Dental
Dec 2014 246d
OSTEOMED EXTREMIFUSE SYSTEM
K140283 · HWC Screw, Fixation, Bone · Orthopedic
Feb 2014 24d
OSTEOMED NEURO RONGEUR
K131851 · HAE Rongeur, Manual · Neurology
Dec 2013 168d
1ST MTP PLATE
K133437 · HRS Plate, Fixation, Bone · Orthopedic
Dec 2013 25d
OSTEOMED EXTREMIFUSE SYSTEM
K130412 · HWC Screw, Fixation, Bone · Orthopedic
May 2013 101d
OSTEOMED CRANIAL DISTRACTION SYSTEM
K121304 · PBJ Cranial Distraction System · Neurology
Aug 2012 113d
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