EVEREST® Spinal System - Sacroiliac Screw Fenestrated, Size Ø10.5x65 mm - K2M, INC.

Duns Number:146060863

Device Description: Sacroiliac Screw Fenestrated, Size Ø10.5x65 mm

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More Product Details

Catalog Number

F2911-01065

Brand Name

EVEREST® Spinal System

Version/Model Number

F2911-01065

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

-

Product Code Details

Product Code

KWP

Product Code Name

APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Device Record Status

Public Device Record Key

e00921fb-c334-4782-b1ad-624ce94cb071

Public Version Date

July 04, 2022

Public Version Number

2

DI Record Publish Date

September 27, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"K2M, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 5699
2 A medical device with a moderate to high risk that requires special controls. 17961