Catalog Number

-

Brand Name

Minuteman G5

Version/Model Number

10-0103-000

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

MRI safety Status

MR Conditional

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

K211880

Product Code

PEK

Product Code Name

Spinous Process Plate

Public Device Record Key

179633a3-5d2b-402a-8839-f4fbf2725b4a

Public Version Date

October 24, 2022

Public Version Number

2

DI Record Publish Date

May 13, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-