Distal Fibula Plating System - Distal Fibula Plate Standard Syndesmosis Screw - GRAMERCY EXTREMITY ORTHOPEDICS LLC

Duns Number:080068420

Device Description: Distal Fibula Plate Standard Syndesmosis Screw Holes, 7-Hole

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More Product Details

Catalog Number

-

Brand Name

Distal Fibula Plating System

Version/Model Number

12660107

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

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

Yes

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

-

Product Code Details

Product Code

HRS

Product Code Name

Plate, fixation, bone

Device Record Status

Public Device Record Key

d8e1b1d5-fdaa-4958-944a-713905f55e8f

Public Version Date

January 18, 2022

Public Version Number

1

DI Record Publish Date

January 10, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GRAMERCY EXTREMITY ORTHOPEDICS LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 65
2 A medical device with a moderate to high risk that requires special controls. 626