Catalog Number

-

Brand Name

Silverbolt/Mainframe

Version/Model Number

200-2225

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

K062670

Product Code

MNH

Product Code Name

Orthosis, spondylolisthesis spinal fixation

Public Device Record Key

0edc4457-9565-478e-8dc8-5550f7d5cb1c

Public Version Date

September 29, 2022

Public Version Number

5

DI Record Publish Date

February 18, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-