Catalog Number

-

Brand Name

OssBuilder System

Version/Model Number

SM3W12129SB

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

K172354

Product Code

JEY

Product Code Name

PLATE, BONE

Public Device Record Key

b9e3ae97-1f32-4a17-b91a-01114f84e9fa

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

April 05, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-