TIGER Spine System - 5508 SERIES PRE-BENT ROD MIS - COBALT CHROME, - CORELINK LLC

Duns Number:064191453

Device Description: 5508 SERIES PRE-BENT ROD MIS - COBALT CHROME, 5.5MM X 60MM

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More Product Details

Catalog Number

R5508-060

Brand Name

TIGER Spine System

Version/Model Number

R5508-060

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K120696

Product Code Details

Product Code

MNH

Product Code Name

Orthosis, spondylolisthesis spinal fixation

Device Record Status

Public Device Record Key

bdbca7ad-ea11-471c-a3e3-be8efa2bff62

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 21, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CORELINK LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 2994