DJO SURGICAL - INS,KNEE,EMPOWR Partial Knee Tibial Insert Trial, - Encore Medical, L.P.

Duns Number:154074504

Device Description: INS,KNEE,EMPOWR Partial Knee Tibial Insert Trial, Sz 6, 8mm

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More Product Details

Catalog Number

-

Brand Name

DJO SURGICAL

Version/Model Number

801-06-070

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

K191325

Product Code Details

Product Code

HSX

Product Code Name

PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Device Record Status

Public Device Record Key

7f3ff5b7-b5c3-496f-aa24-b884e798207c

Public Version Date

May 27, 2020

Public Version Number

1

DI Record Publish Date

May 19, 2020

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