BIOLOX CONTOURA Ceramic Femoral Head - Contura Femoral Head, 36mm head, +7mm head length - TOTAL JOINT ORTHOPEDICS, INC.

Duns Number:078416717

Device Description: Contura Femoral Head, 36mm head, +7mm head length

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More Product Details

Catalog Number

-

Brand Name

BIOLOX CONTOURA Ceramic Femoral Head

Version/Model Number

3206.36.700

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

K191399

Product Code Details

Product Code

LPH

Product Code Name

PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Device Record Status

Public Device Record Key

b5fdaf5a-df49-4651-a45c-0381a6b1bd9a

Public Version Date

September 09, 2020

Public Version Number

2

DI Record Publish Date

September 16, 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