Signature - SIG C/T TKA GDE/MDL SET 03-02 - Materialise NV

Duns Number:373139427

Device Description: SIG C/T TKA GDE/MDL SET 03-02

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More Product Details

Catalog Number

42-422750

Brand Name

Signature

Version/Model Number

42-422750

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 01, 2019

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K110415,K110415

Product Code Details

Product Code

HRY

Product Code Name

Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer

Device Record Status

Public Device Record Key

6595c3db-8e22-4731-b6cf-f6deb2990227

Public Version Date

November 27, 2019

Public Version Number

5

DI Record Publish Date

July 21, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MATERIALISE NV" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 91
2 A medical device with a moderate to high risk that requires special controls. 296