DJO SURGICAL - EMPOWR 3D KNEETM, PRESS FIT FEMUR, 8L - Encore Medical, L.P.

Duns Number:154074504

Device Description: EMPOWR 3D KNEETM, PRESS FIT FEMUR, 8L

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More Product Details

Catalog Number

-

Brand Name

DJO SURGICAL

Version/Model Number

243-01-108

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K171991

Product Code Details

Product Code

MBH

Product Code Name

PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER

Device Record Status

Public Device Record Key

c18b4c2e-2568-4908-b490-fb11287a73dc

Public Version Date

August 01, 2018

Public Version Number

4

DI Record Publish Date

October 25, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ENCORE MEDICAL, L.P." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2340
2 A medical device with a moderate to high risk that requires special controls. 3474
3 A medical device with high risk that requires premarket approval 26