ANATOMIC - ANATOMIC® Posterior Stabilized Fixed Bearing - AMPLITUDE SAS

Duns Number:634855407

Device Description: ANATOMIC® Posterior Stabilized Fixed Bearing Insert Size 3 Thickness 10 mm

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More Product Details

Catalog Number

1-0209730

Brand Name

ANATOMIC

Version/Model Number

1-0209730

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"

Yes

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

K161414

Product Code Details

Product Code

JWH

Product Code Name

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

Device Record Status

Public Device Record Key

fdac2435-b7b9-46a7-a83c-026b7adcfbc2

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 07, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"AMPLITUDE SAS" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 499