Mosaic - Ø4.5 x 12MM VARIABLE-ANGLE SCREW - SPINAL ELEMENTS, INC.

Duns Number:610712213

Device Description: Ø4.5 x 12MM VARIABLE-ANGLE SCREW

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More Product Details

Catalog Number

-

Brand Name

Mosaic

Version/Model Number

25045-012

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 09, 2019

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

-

Product Code Details

Product Code

OVE

Product Code Name

Intervertebral fusion device with integrated fixation, cervical

Device Record Status

Public Device Record Key

c7b430a3-0b50-4f35-9692-aef1f9c6d253

Public Version Date

February 24, 2020

Public Version Number

4

DI Record Publish Date

June 24, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SPINAL ELEMENTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 4289
2 A medical device with a moderate to high risk that requires special controls. 2600