Catalog Number

PITI-2.0 Ball Screw

Brand Name

Tatum Surgical ITI Integrity Ball Screw

Version/Model Number

PITI 2.0 Ball Screw

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

K811923

Product Code

NDP

Product Code Name

Accessories, Implant, Dental, Endosseous

Public Device Record Key

7f10b4b4-2810-4461-b8a9-1a2fafd325c6

Public Version Date

July 21, 2021

Public Version Number

3

DI Record Publish Date

January 30, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-