Catalog Number

025-006

Brand Name

Fine osteotomy System

Version/Model Number

025-006

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

K211646

Product Code

HRS

Product Code Name

Plate, Fixation, Bone

Public Device Record Key

f637bd59-ec24-4f65-b62e-a3790f8dbfe8

Public Version Date

December 22, 2021

Public Version Number

1

DI Record Publish Date

December 13, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-