Sacroiliac Joint Fusion System - 8.5mm SI Washer - Genesys Orthopedics Systems LLC

Duns Number:017921066

Device Description: 8.5mm SI Washer

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More Product Details

Catalog Number

GSI-W085

Brand Name

Sacroiliac Joint Fusion System

Version/Model Number

1

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

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

K191748

Product Code Details

Product Code

OUR

Product Code Name

Sacroiliac Joint Fixation

Device Record Status

Public Device Record Key

a0af5e91-bf31-4720-815b-732a2cf162c9

Public Version Date

December 19, 2019

Public Version Number

1

DI Record Publish Date

December 11, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GENESYS ORTHOPEDICS SYSTEMS LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 9
2 A medical device with a moderate to high risk that requires special controls. 4608