Taperloc® Microplasty® Complete - Biomet Orthopedics, LLC

Duns Number:129278169

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More Product Details

Catalog Number

51-206090

Brand Name

Taperloc® Microplasty® Complete

Version/Model Number

51-206090

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

-

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

K120030,K110400

Product Code Details

Product Code

JDI

Product Code Name

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

Device Record Status

Public Device Record Key

c701a6ef-b9a5-4f18-a82b-771c2ee4a3a1

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

May 26, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BIOMET ORTHOPEDICS, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 11962
2 A medical device with a moderate to high risk that requires special controls. 28376
3 A medical device with high risk that requires premarket approval 36
U Unclassified 4