Lever Action Plate System - Plates MCG-RC1F AND MCG-RD1F GUIDE BLOCK - MCGINLEY ORTHOPAEDIC INNOVATIONS, LLC

Duns Number:078568266

Device Description: Plates MCG-RC1F AND MCG-RD1F GUIDE BLOCK

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More Product Details

Catalog Number

MCG-RCD1FG

Brand Name

Lever Action Plate System

Version/Model Number

0

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

MR Conditional

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K200834

Product Code Details

Product Code

HRS

Product Code Name

Plate, Fixation, Bone

Device Record Status

Public Device Record Key

990408af-21f8-4ecb-b894-08c3c7f5152e

Public Version Date

November 24, 2020

Public Version Number

1

DI Record Publish Date

November 16, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MCGINLEY ORTHOPAEDIC INNOVATIONS, LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 91