Catalog Number

357052

Brand Name

NA

Version/Model Number

357.052

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

K092646,K092646

Product Code

HSB

Product Code Name

ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Public Device Record Key

89f4c2e9-faf8-4a84-a3d9-19363b564fcc

Public Version Date

May 02, 2022

Public Version Number

5

DI Record Publish Date

September 14, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-