FDA.reportPublic FDA data

Lever Action Plate System

Primary DI
B666MCGRB2V0
Brand
Lever Action Plate System
Company
MCGINLEY ORTHOPAEDIC INNOVATIONS, LLC
Model
0
Catalog number
MCG-RB2V
Device description
RIGHT PLATE, SMALL, NARROW, 2 BEAMS, VARIABLE
Published
2020-11-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRSPlate, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200834000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200834000Lever Action Plate SystemMcginley Orthpaedic Innovations, LLC2020-06-25HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B666MCGRB2V0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic fixation plate, non-bioabsorbableA non-bioabsorbable, non-customized, firm, implantable sheet intended to stabilize a fractured orthopaedic bone (excluding craniofacial and spinal) to treat a traumatic/pathological fracture, to fuse a joint (arthrodesis) and/or as part of an osteotomy. Typically attached to a bone of a limb, rib, sternum, or pelvis, it is designed to be fixed in place with screws; it does not incorporate a sleeve or blade. Instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be included with the plate.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
307-315-6403support@mcginleyinnovations.com

Regulatory Flags#

DUNS number
078568266
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B666MCGLD2F0Lever Action Plate System0MCG-LD2F2025-09-23
B666MCGRD2F0Lever Action Plate System0MCG-RD2F2025-09-23
B666MCGLA1F0Lever Action Plate System0MCG-LA1F2020-11-16
B666MCGLA2V0Lever Action Plate System0MCG-LA2V2020-11-16
B666MCGLB1F0Lever Action Plate System0MCG-LB1F2020-11-16
B666MCGLB2V0Lever Action Plate System0MCG-LB2V2020-11-16
B666MCGLC1F0Lever Action Plate System0MCG-LC1F2020-11-16
B666MCGLC2V0Lever Action Plate System0MCG-LC2V2020-11-16
B666MCGLD1F0Lever Action Plate System0MCG-LD1F2020-11-16
B666MCGLD2V0Lever Action Plate System0MCG-LD2V2020-11-16
B666MCGLE1F0Lever Action Plate System0MCG-LE1F2020-11-16
B666MCGLE2V0Lever Action Plate System 0MCG-LE2V2020-11-16
B666MCGLF1F0Lever Action Plate System0MCG-LF1F2020-11-16
B666MCGLF2V0Lever Action Plate System0MCG-LF2V2020-11-16
B666MCGRA1F0Lever Action Plate System0MCG-RA1F2020-11-16
B666MCGRA2V0Lever Action Plate System0MCG-RA2V2020-11-16
B666MCGRB1F0Lever Action Plate System0MCG-RB1F2020-11-16
B666MCGRC1F0Lever Action Plate System0MCG-RC1F2020-11-16
B666MCGRC2V0Lever Action Plate System0MCG-RC2V2020-11-16
B666MCGRD1F0Lever Action Plate System0MCG-RD1F2020-11-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810136433593OptimalMTP®Forma Medical, Inc.HRS2026-10-16
00810136433609OptimalMTP®Forma Medical, Inc.HRS2026-10-16
05055662976649Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHRS2026-10-06
05055662976656Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHRS2026-10-06
05055662976663Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHRS2026-10-06
05055662976670Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHRS2026-10-06
05055662976687Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHRS2026-10-06
03700569631840Alians ForearmNEWCLIP TECHNICSHRS2026-10-01
03700569631857Alians ForearmNEWCLIP TECHNICSHRS2026-10-01
00888118131867LEVEL ONE EXTREMITY, STERILEKLS-Martin L.P.HRS2026-04-23
00888118132529LEVEL ONE EXTREMITYKLS-Martin L.P.HRS2026-04-23
08809986482815CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-04-17
08809986482822CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-04-17
08809986482839CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-04-17
08809986482846CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-04-17
08809986482853CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-04-17
08809986482860CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-04-17
08809986482778CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2025-07-21
08809986482785CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2025-07-21
08809986482716CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2025-07-18
08809986482723CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2025-07-18
08809986482730CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2025-07-18
08809986482747CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2025-07-18
08809986482754CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2025-07-18
08809986482761CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2025-07-18
00810112599268TriLEAPCROSSROADS EXTREMITY SYSTEMSHRS2025-03-17
00810112593341TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHRS2024-02-22
00885556838211Total Foot System 2Smith & Nephew, Inc.HRS2023-04-18
B562PKSMC0835NSLTIUS0Superior Mid-Shaft Narrow Straight Clavicle Plate Procedure Kit 8 hole, LeftWishbone Medical, Inc.HRS2019-09-06
B562PKSMC0835NSRTIUS0Superior Mid-Shaft Narrow Straight Clavicle Plate Procedure Kit 8 hole, RightWishbone Medical, Inc.HRS2019-09-06