CATAMARAN™ SIJ Fusion System - Inserter Screw 10mm, Catamaran - TENON MEDICAL, INC.

Duns Number:117014636

Device Description: Inserter Screw 10mm, Catamaran

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More Product Details

Catalog Number

40336

Brand Name

CATAMARAN™ SIJ Fusion System

Version/Model Number

40336

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K180818

Product Code Details

Product Code

OUR

Product Code Name

Sacroiliac Joint Fixation

Device Record Status

Public Device Record Key

82dd9191-4a1b-4353-aed3-22b29df0af9e

Public Version Date

December 27, 2021

Public Version Number

1

DI Record Publish Date

December 17, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TENON MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 81