SPEEDBUTTON - The SPEEDBUTTON™ Suture Anchor is intended to be - CROSSROADS EXTREMITY SYSTEMS

Duns Number:058864308

Device Description: The SPEEDBUTTON™ Suture Anchor is intended to be used for suture or tissue fixation in the The SPEEDBUTTON™ Suture Anchor is intended to be used for suture or tissue fixation in the foot and ankle. Specific indications are listed below: Foot/Ankle: Lateral Stabilization, Medial Stabilization, Metatarsal Ligament Repair, Hallux Valgus reconstruction

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More Product Details

Catalog Number

32SB-KIT1

Brand Name

SPEEDBUTTON

Version/Model Number

SpeedButton Kit 1x4mm

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

MBI

Product Code Name

Fastener, Fixation, Nondegradable, Soft Tissue

Device Record Status

Public Device Record Key

c42ab1c2-69c3-4097-bf0f-81ed7dd4d47c

Public Version Date

February 01, 2021

Public Version Number

1

DI Record Publish Date

January 22, 2021

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