EVEREST® Spinal System - Straight Rod, Dual Hex, Size Ø6.0x600 mm, CoCr - K2M, INC.

Duns Number:146060863

Device Description: Straight Rod, Dual Hex, Size Ø6.0x600 mm, CoCr

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More Product Details

Catalog Number

2911-B60600-G1

Brand Name

EVEREST® Spinal System

Version/Model Number

2911-B60600-G1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

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

-

Product Code Details

Product Code

KWP

Product Code Name

APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Device Record Status

Public Device Record Key

a5a437cf-cbd7-4aa1-b273-718dfbfb65c8

Public Version Date

July 04, 2022

Public Version Number

2

DI Record Publish Date

October 07, 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