BioHorizons - Fusion 3.8 x 10.5mm Implant, Grey Platform, - BIOHORIZONS IMPLANT SYSTEMS, INC

Duns Number:967279910

Device Description: Fusion 3.8 x 10.5mm Implant, Grey Platform, Ossean, Blossom

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More Product Details

Catalog Number

-

Brand Name

BioHorizons

Version/Model Number

IL-3810

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

K121787

Product Code Details

Product Code

DZE

Product Code Name

Implant, Endosseous, Root-Form

Device Record Status

Public Device Record Key

999ebbd7-32b3-4b7c-a17d-ba1115e05df0

Public Version Date

April 27, 2021

Public Version Number

1

DI Record Publish Date

April 19, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BIOHORIZONS IMPLANT SYSTEMS, INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 569
2 A medical device with a moderate to high risk that requires special controls. 982