Catalog Number

57100025

Brand Name

OsteoTorrent C

Version/Model Number

57100025

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"

Yes

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)

Yes

FDA Premarket Submission

K212135

Product Code

MBP

Product Code Name

Filler, bone void, osteoinduction (w/o human growth factor)

Public Device Record Key

c5112e4e-f096-47a5-b591-0e0a41ee796f

Public Version Date

February 24, 2022

Public Version Number

1

DI Record Publish Date

February 16, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-