AFX - LATERAL FIBULA PLATE, 4-HOLE, RIGHT, TRIAL - IN2BONES USA, LLC

Duns Number:079700711

Device Description: LATERAL FIBULA PLATE, 4-HOLE, RIGHT, TRIAL

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More Product Details

Catalog Number

-

Brand Name

AFX

Version/Model Number

P07 N1104

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

-

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

K181113

Product Code Details

Product Code

HRS

Product Code Name

Plate, Fixation, Bone

Device Record Status

Public Device Record Key

dbed2796-e803-4872-a01b-341b8c6fad00

Public Version Date

April 21, 2021

Public Version Number

3

DI Record Publish Date

October 22, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"IN2BONES USA, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 113
2 A medical device with a moderate to high risk that requires special controls. 1255