Level Action Plate System - Key periosteal elevator, 6 7/8'', slightly - MCGINLEY ORTHOPAEDIC INNOVATIONS, LLC

Duns Number:078568266

Device Description: Key periosteal elevator, 6 7/8'', slightly curved, 3.0mm wide blade, hexagonal handle

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More Product Details

Catalog Number

MCG9005

Brand Name

Level 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

47293d48-2003-4928-a979-2e69cffaa6bb

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