LCU Hip Stem - Hip Prosthesis Stem, Taper 12 / 14 - WALDEMAR LINK GmbH & Co. KG

Duns Number:315675488

Device Description: Hip Prosthesis Stem, Taper 12 / 14

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More Product Details

Catalog Number

-

Brand Name

LCU Hip Stem

Version/Model Number

165-314/26

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

K161840

Product Code Details

Product Code

LZO

Product Code Name

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Device Record Status

Public Device Record Key

b3925832-b21d-4d31-9748-24e0dd57535f

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

May 16, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"WALDEMAR LINK GMBH & CO. KG" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 154
2 A medical device with a moderate to high risk that requires special controls. 3922
U Unclassified 42