Catalog Number

-

Brand Name

Tsolution One Surgical System

Version/Model Number

103306

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K153647,K153647

Product Code

OLO

Product Code Name

Orthopedic stereotaxic instrument

Public Device Record Key

825d54e1-a7fe-4e2f-9e02-090f576d34b5

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

M9461033062

Quantity per Package

5

Contains DI Package

M9461033060

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-