Alteon - Alteon Highly Polished Femoral Stem - Exactech, Inc.

Duns Number:157565946

Device Description: Alteon Highly Polished Femoral Stem

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More Product Details

Catalog Number

190-60-10

Brand Name

Alteon

Version/Model Number

190-60-10

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

K182462

Product Code Details

Product Code

KWL

Product Code Name

Prosthesis, Hip, Hemi-, Femoral, Metal

Device Record Status

Public Device Record Key

9483f78c-a7b8-441e-8f08-3fbd4bb14998

Public Version Date

January 03, 2019

Public Version Number

1

DI Record Publish Date

December 03, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"EXACTECH, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3717
2 A medical device with a moderate to high risk that requires special controls. 7206
3 A medical device with high risk that requires premarket approval 28