Nexxt Spine Navigation System

GUDID 00889929059241

Ø3.0mm Navigated Drill

NEXXT SPINE, LLC

General internal orthopaedic fixation system implantation kit
Primary Device ID00889929059241
NIH Device Record Key371a62f9-9612-4788-889a-82fa4bfa31c2
Commercial Distribution StatusIn Commercial Distribution
Brand NameNexxt Spine Navigation System
Version Model NumberI12NAV-830
Company DUNS003489810
Company NameNEXXT SPINE, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone317-436-7801
EmailSupport@nexxtspine.com
Phone317-436-7801
EmailSupport@nexxtspine.com
Phone317-436-7801
EmailSupport@nexxtspine.com
Phone317-436-7801
EmailSupport@nexxtspine.com
Phone317-436-7801
EmailSupport@nexxtspine.com
Phone317-436-7801
EmailSupport@nexxtspine.com
Phone317-436-7801
EmailSupport@nexxtspine.com
Phone317-436-7801
EmailSupport@nexxtspine.com
Phone317-436-7801
EmailSupport@nexxtspine.com
Phone317-436-7801
EmailSupport@nexxtspine.com
Phone317-436-7801
EmailSupport@nexxtspine.com
Phone317-436-7801
EmailSupport@nexxtspine.com

Device Dimensions

Outer Diameter3 Millimeter
Outer Diameter3 Millimeter
Outer Diameter3 Millimeter
Outer Diameter3 Millimeter
Outer Diameter3 Millimeter
Outer Diameter3 Millimeter
Outer Diameter3 Millimeter
Outer Diameter3 Millimeter
Outer Diameter3 Millimeter
Outer Diameter3 Millimeter
Outer Diameter3 Millimeter
Outer Diameter3 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100889929059241 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLOOrthopedic Stereotaxic Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00889929059241]

Moist Heat or Steam Sterilization


[00889929059241]

Moist Heat or Steam Sterilization


[00889929059241]

Moist Heat or Steam Sterilization


[00889929059241]

Moist Heat or Steam Sterilization


[00889929059241]

Moist Heat or Steam Sterilization


[00889929059241]

Moist Heat or Steam Sterilization


[00889929059241]

Moist Heat or Steam Sterilization


[00889929059241]

Moist Heat or Steam Sterilization


[00889929059241]

Moist Heat or Steam Sterilization


[00889929059241]

Moist Heat or Steam Sterilization


[00889929059241]

Moist Heat or Steam Sterilization


[00889929059241]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-12-20
Device Publish Date2024-12-12

On-Brand Devices [Nexxt Spine Navigation System]

00889929045756Navigated Tap, 75mm
00889929045749Navigated Tap, 65mm
00889929045732Navigated Tap, 55mm
00889929045725Navigated Tap, 45mm
00889929045718Navigated Auto-Locking Inserter
00889929045701Navigated Awl, 9mm
00889929045695Navigated Straight Probe, Thoracic Lenke
00889929053430Navigated Drill, Ø3.5mm
00889929053003Connexx Cannulated Navigation Instrument Case
00889929052990Connexx Navigation Instrument Case
00889929052419Navigated MIS Screw Inserter
008899290524028.5mm Navigated Cann. Tap
008899290523967.5mm Navigated Cann. Tap
008899290523896.5mm Navigated Cann. Tap
008899290523725.5mm Navigated Cann. Tap
008899290523654.5mm Navigated Cann. Tap
00889929052358Navigated Cannulated Screw Inserter
00889929052341Navigated Cannulated Shank Inserter
00889929052334Navigated Reduction Screw Inserter
00889929052327Navigated Screw Inserter
00889929052310Navigated Shank Inserter
0088992905230311.5mm Navigated Tap
0088992905229710.5mm Navigated Tap
008899290522809.5mm Navigated Tap
008899290522738.5mm Navigated Tap
008899290522667.5mm Navigated Tap
008899290522596.5mm Navigated Tap
008899290522425.5mm Navigated Tap
008899290522354.5mm Navigated Tap
008899290522284.0mm Navigated Tap
00889929052211Navigated Iliac Pedicle Probe, Steffe Straight
00889929052204Navigated Lumbar Pedicle Probe, Lenke Straight
00889929052198Navigated Thoracic Pedicle Probe, Lenke Straight
00889929053522Connexx Cannulated Navigation Instrument Case
00889929053515Connexx Navigation Instrument Case
0088992905605911.5mm Navigated Cann. Tap
0088992905604210.5mm Navigated Cann. Tap
008899290560359.5mm Navigated Cann. Tap
00889929058237Navigated Cannulated Shank Inserter, Locking
00889929058206Navigated MIS + Reduction Screw Inserter, Locking
00889929058190Navigated Cannulated Screw Inserter, Locking
00889929059272Navigated Auto Locking Inserter
00889929059265Navigated Awl
00889929059258Ø3.5mm Navigated Drill
00889929059241Ø3.0mm Navigated Drill
00889929059234Ø2.5mm Navigated Drill
00889929059227Ø2.0mm Navigated Drill
00889929059210Ø5.0mm Navigated Tap
00889929059203Ø4.5mm Navigated Tap
00889929059197Ø4.0mm Navigated Tap

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