OrthoMedFlex - Kratos Hip Stem, SIZE 14 Lateral Offset, Ti6AI4V - ORTHOMEDFLEX LLC

Duns Number:034442726

Device Description: Kratos Hip Stem, SIZE 14 Lateral Offset, Ti6AI4V Alloy with HA Coating

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More Product Details

Catalog Number

AS-214

Brand Name

OrthoMedFlex

Version/Model Number

AS-214

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)

-

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

MEH

Product Code Name

Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate

Device Record Status

Public Device Record Key

140cabc5-908a-40c2-9b7b-723a10ea9431

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 13, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ORTHOMEDFLEX LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 371
2 A medical device with a moderate to high risk that requires special controls. 435