Catalog Number

-

Brand Name

Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)

Version/Model Number

P070-6005

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

-

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

K073669

Product Code

HXC

Product Code Name

WRENCH

Public Device Record Key

888ffa84-c5c3-4fb6-9397-5631220215e9

Public Version Date

February 24, 2020

Public Version Number

4

DI Record Publish Date

July 29, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-