iFuse Granite Implant System - Bedrock Granite 11.0mm Cannulated Tap - Si-Bone Inc.

Duns Number:830127168

Device Description: Bedrock Granite 11.0mm Cannulated Tap

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

iFuse Granite Implant System

Version/Model Number

400302-1100

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

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

K220195

Product Code Details

Product Code

LXH

Product Code Name

Orthopedic Manual Surgical Instrument

Device Record Status

Public Device Record Key

d84f594d-c3b2-4271-8030-dacb0746fcb1

Public Version Date

June 08, 2022

Public Version Number

1

DI Record Publish Date

May 31, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SI-BONE INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 97
2 A medical device with a moderate to high risk that requires special controls. 234