Alpine - Alpine Cemented Stem 10 EXT - Ortho Development Corporation

Duns Number:876542390

Device Description: Alpine Cemented Stem 10 EXT

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More Product Details

Catalog Number

-

Brand Name

Alpine

Version/Model Number

700-1210

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

K153216

Product Code Details

Product Code

JDI

Product Code Name

Prosthesis, hip, semi-constrained, metal/polymer, cemented

Device Record Status

Public Device Record Key

766f6ea2-ba30-4b4e-af20-430154e00fd2

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

May 11, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ORTHO DEVELOPMENT CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3694
2 A medical device with a moderate to high risk that requires special controls. 3650