Nexxt Spine Navigation System - Navigated Tap, 7.5mm - NEXXT SPINE, LLC

Duns Number:003489810

Device Description: Navigated Tap, 7.5mm

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More Product Details

Catalog Number

-

Brand Name

Nexxt Spine Navigation System

Version/Model Number

I10NAV-06-75

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

-

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

K220291

Product Code Details

Product Code

OLO

Product Code Name

Orthopedic Stereotaxic Instrument

Device Record Status

Public Device Record Key

284d66d0-b46c-41f8-b219-e6fb599aac48

Public Version Date

June 17, 2022

Public Version Number

2

DI Record Publish Date

May 25, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NEXXT SPINE, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1102
2 A medical device with a moderate to high risk that requires special controls. 4259
U Unclassified 91