Catalog Number

-

Brand Name

Ti3D Straight Lumbar

Version/Model Number

23-K01-0810

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

K182210

Product Code

HTF

Product Code Name

Curette

Public Device Record Key

8623b497-5742-4506-88aa-c9f485be8959

Public Version Date

July 09, 2020

Public Version Number

1

DI Record Publish Date

July 01, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-