Tsolution One Surgical System - ASSEMBLY, SWIVEL BLOCK - THINK SURGICAL, INC.

Duns Number:007211430

Device Description: ASSEMBLY, SWIVEL BLOCK

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More Product Details

Catalog Number

-

Brand Name

Tsolution One Surgical System

Version/Model Number

103414

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

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

K153647

Product Code Details

Product Code

OLO

Product Code Name

Orthopedic stereotaxic instrument

Device Record Status

Public Device Record Key

243f888b-5290-4ec8-b065-4a7a98bb66dd

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"THINK SURGICAL, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 39