Catalog Number

SCC02-0080

Brand Name

TI rod 6x80mm

Version/Model Number

SCC02-0080

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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"

Yes

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

NKB

Product Code Name

Orthosis, spinal pedicle fixation, for degenerative disc disease

Public Device Record Key

aea0cf14-18ae-447c-837a-17e9b4343c1f

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 04, 2016

Package DI Number

EMAHSCC0200801

Quantity per Package

1

Contains DI Package

EMAHSCC0200800

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-