Catalog Number

-

Brand Name

In2Bones USA

Version/Model Number

P08 N0061

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

K200762

Product Code

LXH

Product Code Name

Orthopedic Manual Surgical Instrument

Public Device Record Key

ec155518-4e94-4a1b-ba41-32524521fd2d

Public Version Date

September 22, 2020

Public Version Number

2

DI Record Publish Date

September 04, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-