Klassic Femur with Cobalt 3D - Femur with Cobalt 3D, size 6 - TOTAL JOINT ORTHOPEDICS, INC.

Duns Number:078416717

Device Description: Femur with Cobalt 3D, size 6

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More Product Details

Catalog Number

-

Brand Name

Klassic Femur with Cobalt 3D

Version/Model Number

5106.06.000

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"

-

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

K162256

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

2f5d8f75-523b-4eaa-8b32-dca232a6da35

Public Version Date

March 11, 2019

Public Version Number

1

DI Record Publish Date

February 28, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TOTAL JOINT ORTHOPEDICS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 880
2 A medical device with a moderate to high risk that requires special controls. 732