EVOLUTION - Microport Orthopedics Inc.

Duns Number:079118736

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More Product Details

Catalog Number

EFSAN1PR

Brand Name

EVOLUTION

Version/Model Number

EFSAN1PR

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

MR Conditional

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

-

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

eceebe80-1643-4125-9657-30ce48f0cfbf

Public Version Date

December 11, 2019

Public Version Number

2

DI Record Publish Date

May 31, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MICROPORT ORTHOPEDICS INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 7823
2 A medical device with a moderate to high risk that requires special controls. 12222
3 A medical device with high risk that requires premarket approval 109