Catalog Number

62-2677-10

Brand Name

Sterile Spine Pedicle Screw System

Version/Model Number

62-2677-10

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K192930

Product Code

MNH

Product Code Name

Orthosis, Spondylolisthesis Spinal Fixation

Public Device Record Key

0d7430f4-3475-40a4-a8fa-220c121a04c7

Public Version Date

July 27, 2022

Public Version Number

1

DI Record Publish Date

July 19, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-