Nexxt Spine Navigation System

GUDID 00889929059210

Ø5.0mm Navigated Tap

NEXXT SPINE, LLC

General internal orthopaedic fixation system implantation kit

• Primary Device ID: 00889929059210
• NIH Device Record Key: 71660acc-6f37-42db-8412-6363eeb89242
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nexxt Spine Navigation System
• Version Model Number: I12NAV-550
• Company DUNS: 003489810
• Company Name: NEXXT SPINE, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 317-436-7801
• Email: Support@nexxtspine.com
• Phone: 317-436-7801
• Email: Support@nexxtspine.com
• Phone: 317-436-7801
• Email: Support@nexxtspine.com
• Phone: 317-436-7801
• Email: Support@nexxtspine.com
• Phone: 317-436-7801
• Email: Support@nexxtspine.com
• Phone: 317-436-7801
• Email: Support@nexxtspine.com
• Phone: 317-436-7801
• Email: Support@nexxtspine.com
• Phone: 317-436-7801
• Email: Support@nexxtspine.com
• Phone: 317-436-7801
• Email: Support@nexxtspine.com
• Phone: 317-436-7801
• Email: Support@nexxtspine.com
• Phone: 317-436-7801
• Email: Support@nexxtspine.com
• Phone: 317-436-7801
• Email: Support@nexxtspine.com

Device Dimensions

• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889929059210 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220291

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00889929059210]

Moist Heat or Steam Sterilization

[00889929059210]

Moist Heat or Steam Sterilization

[00889929059210]

Moist Heat or Steam Sterilization

[00889929059210]

Moist Heat or Steam Sterilization

[00889929059210]

Moist Heat or Steam Sterilization

[00889929059210]

Moist Heat or Steam Sterilization

[00889929059210]

Moist Heat or Steam Sterilization

[00889929059210]

Moist Heat or Steam Sterilization

[00889929059210]

Moist Heat or Steam Sterilization

[00889929059210]

Moist Heat or Steam Sterilization

[00889929059210]

Moist Heat or Steam Sterilization

[00889929059210]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-20
• Device Publish Date: 2024-12-12

On-Brand Devices [Nexxt Spine Navigation System]

• 00889929045756: Navigated Tap, 75mm
• 00889929045749: Navigated Tap, 65mm
• 00889929045732: Navigated Tap, 55mm
• 00889929045725: Navigated Tap, 45mm
• 00889929045718: Navigated Auto-Locking Inserter
• 00889929045701: Navigated Awl, 9mm
• 00889929045695: Navigated Straight Probe, Thoracic Lenke
• 00889929053430: Navigated Drill, Ø3.5mm
• 00889929053003: Connexx Cannulated Navigation Instrument Case
• 00889929052990: Connexx Navigation Instrument Case
• 00889929052419: Navigated MIS Screw Inserter
• 00889929052402: 8.5mm Navigated Cann. Tap
• 00889929052396: 7.5mm Navigated Cann. Tap
• 00889929052389: 6.5mm Navigated Cann. Tap
• 00889929052372: 5.5mm Navigated Cann. Tap
• 00889929052365: 4.5mm Navigated Cann. Tap
• 00889929052358: Navigated Cannulated Screw Inserter
• 00889929052341: Navigated Cannulated Shank Inserter
• 00889929052334: Navigated Reduction Screw Inserter
• 00889929052327: Navigated Screw Inserter
• 00889929052310: Navigated Shank Inserter
• 00889929052303: 11.5mm Navigated Tap
• 00889929052297: 10.5mm Navigated Tap
• 00889929052280: 9.5mm Navigated Tap
• 00889929052273: 8.5mm Navigated Tap
• 00889929052266: 7.5mm Navigated Tap
• 00889929052259: 6.5mm Navigated Tap
• 00889929052242: 5.5mm Navigated Tap
• 00889929052235: 4.5mm Navigated Tap
• 00889929052228: 4.0mm Navigated Tap
• 00889929052211: Navigated Iliac Pedicle Probe, Steffe Straight
• 00889929052204: Navigated Lumbar Pedicle Probe, Lenke Straight
• 00889929052198: Navigated Thoracic Pedicle Probe, Lenke Straight
• 00889929053522: Connexx Cannulated Navigation Instrument Case
• 00889929053515: Connexx Navigation Instrument Case
• 00889929056059: 11.5mm Navigated Cann. Tap
• 00889929056042: 10.5mm Navigated Cann. Tap
• 00889929056035: 9.5mm Navigated Cann. Tap
• 00889929058237: Navigated Cannulated Shank Inserter, Locking
• 00889929058206: Navigated MIS + Reduction Screw Inserter, Locking
• 00889929058190: Navigated Cannulated Screw Inserter, Locking
• 00889929059272: Navigated Auto Locking Inserter
• 00889929059265: Navigated Awl
• 00889929059258: Ø3.5mm Navigated Drill
• 00889929059241: Ø3.0mm Navigated Drill
• 00889929059234: Ø2.5mm Navigated Drill
• 00889929059227: Ø2.0mm Navigated Drill
• 00889929059210: Ø5.0mm Navigated Tap
• 00889929059203: Ø4.5mm Navigated Tap
• 00889929059197: Ø4.0mm Navigated Tap