Lever Action Plate System

Plate, Fixation, Bone

McGinley Orthpaedic Innovations, LLC

The following data is part of a premarket notification filed by Mcginley Orthpaedic Innovations, Llc with the FDA for Lever Action Plate System.

Pre-market Notification Details

• Device ID: K200834
• 510k Number: K200834
• Device Name: Lever Action Plate System
• Classification: Plate, Fixation, Bone
• Applicant: McGinley Orthpaedic Innovations, LLC 2435 King Boulevard #230 Casper, WY 82604
• Contact: Adam M. Johnson
• Correspondent: David Mcgurl; MCRA, LLC 1050 K Street NW, Suite 1000 Washington, DC 20001
• Product Code: HRS
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-03-30
• Decision Date: 2020-06-25

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
B666MCG90150	K200834	000
B666MCGREF2VG0	K200834	000
B666MCGREF1FG0	K200834	000
B666MCGRE2V0	K200834	000
B666MCGRE1F0	K200834	000
B666MCGRD2V0	K200834	000
B666MCGRD1F0	K200834	000
B666MCGRCD2VG0	K200834	000
B666MCGRCD1FG0	K200834	000
B666MCGRC2V0	K200834	000
B666MCGRC1F0	K200834	000
B666MCGRB2V0	K200834	000
B666MCGRF1F0	K200834	000
B666MCGRF2V0	K200834	000
B666MCG100AO200	K200834	000
B666MCG90140	K200834	000
B666MCG90130	K200834	000
B666MCG90110	K200834	000
B666MCG90100	K200834	000
B666MCG90090	K200834	000
B666MCG90080	K200834	000
B666MCG90070	K200834	000
B666MCG90060	K200834	000
B666MCG90050	K200834	000
B666MCG90040	K200834	000
B666MCG100AO250	K200834	000
B666MCGRB1F0	K200834	000
B666MCGRAB2VG0	K200834	000
B666MCGRAB1FG0	K200834	000
B666MCGLB2V0	K200834	000
B666MCGLB1F0	K200834	000
B666MCGLAB1FG0	K200834	000
B666MCGLA2V0	K200834	000
B666MCGLA1F0	K200834	000
B666MCGB210	K200834	000
B666MCGB170	K200834	000
B666MCG90230	K200834	000
B666MCGRD2F0	K200834	000
B666MCGRCD2FG0	K200834	000
B666MCGLD2F0	K200834	000
B666MCGLC1F0	K200834	000
B666MCGLC2V0	K200834	000
B666MCGLCD1FG0	K200834	000
B666MCGRA2V0	K200834	000
B666MCGRA1F0	K200834	000
B666MCGLF2V0	K200834	000
B666MCGLF1F0	K200834	000
B666MCGLEF2VG0	K200834	000
B666MCGLEF1FG0	K200834	000
B666MCGLE2V0	K200834	000
B666MCGLE1F0	K200834	000
B666MCGLD2V0	K200834	000
B666MCGLD1F0	K200834	000
B666MCGLCD2VG0	K200834	000
B666MCGLCD2FG0	K200834	000
B666MCG90170	K200834	000
B666MCGP18240	K200834	000
B666MCGS200	K200834	000
B666MCGS190	K200834	000
B666MCGS180	K200834	000
B666MCGS170	K200834	000
B666MCGS160	K200834	000
B666MCGS150	K200834	000
B666MCGS140	K200834	000
B666MCGS130	K200834	000
B666MCGS120	K200834	000
B666MCGN25240	K200834	000
B666MCGN25220	K200834	000
B666MCGS210	K200834	000
B666MCGS220	K200834	000
B666MCG90200	K200834	000
B666MCGP18220	K200834	000
B666MCGP18200	K200834	000
B666MCGP18180	K200834	000
B666MCGP18160	K200834	000
B666MCGP18140	K200834	000
B666MCGP18130	K200834	000
B666MCGP18120	K200834	000
B666MCGP18110	K200834	000
B666MCGP18100	K200834	000
B666MCG90220	K200834	000
B666MCG90210	K200834	000
B666MCGN25200	K200834	000
B666MCGN25180	K200834	000
B666MCGN25160	K200834	000
B666MCGL25100	K200834	000
B666MCGB220	K200834	000
B666MCGB190	K200834	000
B666MCGB160	K200834	000
B666MCG90030	K200834	000
B666MCG90020	K200834	000
B666MCG90010	K200834	000
B666MCG90000	K200834	000
B666MCGLAB2VG0	K200834	000
B666MCGK60620	K200834	000
B666MCGK40620	K200834	000
B666MCGL25110	K200834	000
B666MCGL25120	K200834	000
B666MCGL25130	K200834	000
B666MCGN25140	K200834	000
B666MCGN25130	K200834	000
B666MCGN25120	K200834	000
B666MCGN25110	K200834	000
B666MCGN25100	K200834	000
B666MCGL25240	K200834	000
B666MCGL25220	K200834	000
B666MCGL25200	K200834	000
B666MCGL25180	K200834	000
B666MCGL25160	K200834	000
B666MCGL25140	K200834	000
B666MCG90180	K200834	000