FDA.reportPublic FDA data

Lever Action Plate System

Primary DI
B666MCG90230
Brand
Lever Action Plate System
Company
MCGINLEY ORTHOPAEDIC INNOVATIONS, LLC
Model
0
Catalog number
MCG9023
Device description
SCREWDRIVER, T6, AO STYLE
Published
2024-07-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
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
B666MCG90230PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
General internal orthopaedic fixation system implantation kitA collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. This is a reusable device.

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
Primary DIBrandCompanyProduct codePublished
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08809986479945CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-06-08
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03700569658151Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569658175Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569658199Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569662202Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663247Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663841Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663865Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663872Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663889Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663896Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663902Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663919Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663926Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663933Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663940Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663964Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569671327Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569676438Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569676445Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569676452Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569676469Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
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00850080543030PC Fix Extrathoracic Plate 70mm TiChest Wall Innovations, Inc.HRS2026-06-01
00850080543047PC Fix Extrathoracic Plate 95mm TiChest Wall Innovations, Inc.HRS2026-06-01
00850080543054PC Fix Intrathoracic Plate 70mm TiChest Wall Innovations, Inc.HRS2026-06-01