Catalog Number

SCC02-0500

Brand Name

TI rod 6x500mm

Version/Model Number

SCC02-0500

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

MRI safety Status

MR Safe

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"

Yes

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

NKB

Product Code Name

Orthosis, spinal pedicle fixation, for degenerative disc disease

Public Device Record Key

d2e6469c-2680-43e9-8d7c-d0c19180330a

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

July 07, 2016

Package DI Number

EMAHSCC0205001

Quantity per Package

1

Contains DI Package

EMAHSCC0205000

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-