C2 Hip - C2 Hip - Stem #0 H=132 mm - Taper 12/14 - LIMACORPORATE SPA

Duns Number:432066322

Device Description: C2 Hip - Stem #0 H=132 mm - Taper 12/14

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More Product Details

Catalog Number

4510.15.020

Brand Name

C2 Hip

Version/Model Number

Stem

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

K170473

Product Code Details

Product Code

KWY

Product Code Name

Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented

Device Record Status

Public Device Record Key

7bea5e2d-0af5-4d47-b12e-395772b5da06

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

February 01, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"LIMACORPORATE SPA" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 595
2 A medical device with a moderate to high risk that requires special controls. 3634