Catalog Number

597009

Brand Name

OSSEOTI RECONSTRUCTIVE WEDGE

Version/Model Number

597009

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

K122770

Product Code

HRS

Product Code Name

Plate, fixation, bone

Public Device Record Key

34c2316e-f2b3-4599-a6cd-70ab423f1777

Public Version Date

September 16, 2022

Public Version Number

9

DI Record Publish Date

July 28, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-