VHS VARI-ANGLE HIP SCREW - Biomet Orthopedics, LLC

Duns Number:129278169

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More Product Details

Catalog Number

16-235342

Brand Name

VHS VARI-ANGLE HIP SCREW

Version/Model Number

16-235342

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

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

K011603

Product Code Details

Product Code

KTT

Product Code Name

APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Device Record Status

Public Device Record Key

196416b5-d911-4d08-b672-1b2519612f3d

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 24, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BIOMET ORTHOPEDICS, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 11962
2 A medical device with a moderate to high risk that requires special controls. 28376
3 A medical device with high risk that requires premarket approval 36
U Unclassified 4