Lever Action Plate System

FDA UDI

Class II (US FDA UDI)

by Mcginley Orthopaedic Innovations, Inc

Identity

Trade Name: Lever Action Plate System FDA UDI
Generic Name: Orthopaedic fixation plate, non-bioabsorbable FDA UDI
Device Name: LEFT PLATE, SMALL, WIDE, 2 BEAMS, VARIABLE FDA UDI
Model / Reference: 0 FDA UDI
Description: LEFT PLATE, SMALL, WIDE, 2 BEAMS, VARIABLE FDA UDI

Identifiers

Catalog Number: MCG-LF2V FDA UDI
Primary DI / UDI-DI: B666MCGLF2V0 FDA UDI
510(k) Number: K200834 FDA UDI
FDA Product Code: HRS FDA UDI
GMDN Term: Orthopaedic fixation plate, non-bioabsorbable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3030 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Orthopaedic fixation plate, non-bioabsorbable

Lever Action Plate System by Mcginley Orthopaedic Innovations, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Mcginley Orthopaedic Innovations, Inc

Sources (1)

FDA UDI 9a87f397-c1f2-4dfa-a4a9-eb34003410f3 36 fields · synced Jun 1, 2026