Catalog Number

551-4550

Brand Name

Threshold V2 Pedicle Screw

Version/Model Number

10-10-80-86

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

MRI safety Status

MR Unsafe

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

K172107

Product Code

NKB

Product Code Name

Thoracolumbosacral pedicle screw system

Public Device Record Key

d69b3623-5c93-454a-b118-90b50fe3576a

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 21, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-