| Primary Device ID | 00889929052327 |
| NIH Device Record Key | b6c6d144-1230-4d51-869e-b31f03f56d61 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Nexxt Spine Navigation System |
| Version Model Number | I20NAV-08-02 |
| 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 |
| Phone | 317-436-7801 |
| Support@nexxtspine.com | |
| Phone | 317-436-7801 |
| Support@nexxtspine.com | |
| Phone | 317-436-7801 |
| Support@nexxtspine.com | |
| Phone | 317-436-7801 |
| Support@nexxtspine.com | |
| Phone | 317-436-7801 |
| Support@nexxtspine.com | |
| Phone | 317-436-7801 |
| Support@nexxtspine.com | |
| Phone | 317-436-7801 |
| Support@nexxtspine.com | |
| Phone | 317-436-7801 |
| Support@nexxtspine.com | |
| Phone | 317-436-7801 |
| Support@nexxtspine.com | |
| Phone | 317-436-7801 |
| Support@nexxtspine.com | |
| Phone | 317-436-7801 |
| Support@nexxtspine.com | |
| Phone | 317-436-7801 |
| Support@nexxtspine.com | |
| Phone | 317-436-7801 |
| Support@nexxtspine.com | |
| Phone | 317-436-7801 |
| Support@nexxtspine.com | |
| Phone | 317-436-7801 |
| Support@nexxtspine.com | |
| Phone | 317-436-7801 |
| Support@nexxtspine.com | |
| Phone | 317-436-7801 |
| Support@nexxtspine.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00889929052327 [Primary] |
| OLO | Orthopedic Stereotaxic Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00889929052327]
Moist Heat or Steam Sterilization
[00889929052327]
Moist Heat or Steam Sterilization
[00889929052327]
Moist Heat or Steam Sterilization
[00889929052327]
Moist Heat or Steam Sterilization
[00889929052327]
Moist Heat or Steam Sterilization
[00889929052327]
Moist Heat or Steam Sterilization
[00889929052327]
Moist Heat or Steam Sterilization
[00889929052327]
Moist Heat or Steam Sterilization
[00889929052327]
Moist Heat or Steam Sterilization
[00889929052327]
Moist Heat or Steam Sterilization
[00889929052327]
Moist Heat or Steam Sterilization
[00889929052327]
Moist Heat or Steam Sterilization
[00889929052327]
Moist Heat or Steam Sterilization
[00889929052327]
Moist Heat or Steam Sterilization
[00889929052327]
Moist Heat or Steam Sterilization
[00889929052327]
Moist Heat or Steam Sterilization
[00889929052327]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-08-15 |
| Device Publish Date | 2023-08-07 |
| 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 |