CrossRoads™ Bone Screw - CrossRoads™ Bone Screw System is used for - CROSSROADS EXTREMITY SYSTEMS

Duns Number:058864308

Device Description: CrossRoads™ Bone Screw System is used for fracture repair and fixation, osteotomy, joint f CrossRoads™ Bone Screw System is used for fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of bones appropriate for the size of the bone screw.

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More Product Details

Catalog Number

1408-3020

Brand Name

CrossRoads™ Bone Screw

Version/Model Number

Headless

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

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

-

Product Code Details

Product Code

HWC

Product Code Name

Screw, Fixation, Bone

Device Record Status

Public Device Record Key

4d046845-b5de-4de7-8011-302c0d8a8bd4

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

May 06, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CROSSROADS EXTREMITY SYSTEMS" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 59
2 A medical device with a moderate to high risk that requires special controls. 713