FDA.reportPublic FDA data

Lever Action Plate System

Primary DI
B666MCGP18200
Brand
Lever Action Plate System
Company
MCGINLEY ORTHOPAEDIC INNOVATIONS, LLC
Model
0
Catalog number
MCG-P1820
Device description
1.8MM x 20MM LOCKING PEG
Published
2023-06-13
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
B666MCGP18200PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterileA non-sterile assembly of implantable devices designed for the stabilization of fractured/surgically-cut bones of the limbs (long bones), their appendages (hands, feet), pelvis, craniomaxillofacial bones, and/or for limb-joint fusion. It typically consists of a set of bone fixation plates, screws, wires, and pins made of materials that cannot be chemically degraded or absorbed via natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). It may also include instruments for the attachment of the implants such as screwdrivers or drills. This device is intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
3073156403support@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
B666MCGRB2V0Lever Action Plate System0MCG-RB2V2020-11-16
B666MCGRC1F0Lever Action Plate System0MCG-RC1F2020-11-16
B666MCGRC2V0Lever Action Plate System0MCG-RC2V2020-11-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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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
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08809986482846CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-04-17
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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
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