Stealthfix Intraosseous Fixation System - StealthFix Lag Screw 3.5mm x 16mm - Nextremity Solutions, Inc.

Duns Number:060783407

Device Description: StealthFix Lag Screw 3.5mm x 16mm

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More Product Details

Catalog Number

-

Brand Name

Stealthfix Intraosseous Fixation System

Version/Model Number

SF3516

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K220181

Product Code Details

Product Code

HWC

Product Code Name

Screw, Fixation, Bone

Device Record Status

Public Device Record Key

9ea4cf0e-c8a0-486c-b4c4-1405ea204dad

Public Version Date

September 23, 2022

Public Version Number

2

DI Record Publish Date

August 04, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NEXTREMITY SOLUTIONS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 152
2 A medical device with a moderate to high risk that requires special controls. 560