Catalog Number

0851-3060

Brand Name

SpineSmith Fusionary Graft Delivery System

Version/Model Number

0851-3060

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

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

BK090047

Product Code

FMF

Product Code Name

Syringe, Piston

Public Device Record Key

e9f70fd2-e2fd-487b-be8d-c6998b2140d4

Public Version Date

June 10, 2022

Public Version Number

6

DI Record Publish Date

December 29, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-