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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
General internal orthopaedic fixation system implantation kit FDA UDI
Device Name
SCREWDRIVER, T8, AO STYLE FDA UDI
Model / Reference
0 FDA UDI
Description
SCREWDRIVER, T8, AO STYLE FDA UDI

Identifiers

Catalog Number
MCG9021 FDA UDI
Primary DI / UDI-DI
B666MCG90210 FDA UDI
510(k) Number
K200834 FDA UDI
FDA Product Code
HRS FDA UDI
GMDN Term
General internal orthopaedic fixation system implantation kit 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: General internal orthopaedic fixation system implantation kit

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

Similar devices

Also classified as General internal orthopaedic fixation system implantation kit.

Cleared under the same submission

K200834 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Mcginley Orthopaedic Innovations, Inc

Sources (1)

  • FDA UDI bf40fd48-6b13-4948-924a-af0eeea91b6d 36 fields · synced Jun 1, 2026