Flow-Screw™ - 7.3/25mm FT Flow-Screw - Flow-FX

Duns Number:079293587

Device Description: 7.3/25mm FT Flow-Screw

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More Product Details

Catalog Number

73-2025

Brand Name

Flow-Screw™

Version/Model Number

73-2025

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

K142776

Product Code Details

Product Code

HWC

Product Code Name

Screw, Fixation, Bone

Device Record Status

Public Device Record Key

2f297d4e-5a5a-47a0-8668-da8ce5c00d24

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 04, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"FLOW-FX" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 85
2 A medical device with a moderate to high risk that requires special controls. 1067