NEXXT SPINE NAVIGATION System
FDA 510(k) K220291 · Nexxt Spine, LLC
510(k) numberK220291
Submission
- Device name
- NEXXT SPINE NAVIGATION System
- Applicant
- Nexxt Spine, LLC
Noblesville, IN, US - Received
- February 1, 2022
- Decision date
- March 31, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OLO – Orthopedic Stereotaxic Instrument
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.4560
- Specialty
- Neurology
Stereotaxic guidance during orthopedic surgery procedures. Indicated for Orthopedic joint or spine surgery. Neurological stereotaxic instruments are classified under product code HAW.
Other 510(k)s with product code OLO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262506 | Remex Spine Surgery Navigation - Universal InstrumentsOLO · Special | Remex Medical Corp. | 08/20/2026SE |
| K261410 | Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration…OLO · Traditional | Suite 201, National Innovation Centre | 07/30/2026SE |
| K261205 | SPINEART Navigation Instrument SystemOLO · Traditional | Spineart SA | 07/29/2026SE |
| K262121 | Ion-L Navigated InstrumentsOLO · Special | SurGenTec, LLC | 07/24/2026SE |
| K261024 | TMINI Miniature Robotic SystemOLO · Traditional | THINK Surgical, Inc. | 07/24/2026SE |
| K261113 | Op.n Spine Navigation and Robotic GuidanceOLO · Traditional | Ecential Robotics | 07/22/2026SE |
| K261852 | OTS HipOLO · Special | Ortoma AB | 07/01/2026SE |
| K253921 | VERTICALE® Navigation InstrumentsOLO · Traditional | Silony Medical GmbH | 06/26/2026SE |
| K260480 | VELYS Robotic-Assisted SolutionOLO · Traditional | Depuy Ireland UC | 06/25/2026SE |
| K260369 | Dynamis Robotic Surgical SystemOLO · Traditional | LEM Surgical AG | 06/20/2026SE |
More from LEM Surgical AG
| 510(k) | Device | Decision |
|---|---|---|
| K243838 | NEXXT MATRIXX® SI SystemOUR · Traditional | 03/14/2025SE |
| K240690 | STRUXXURE® MCS Anterior Cervical Plate SystemKWQ · Special | 03/22/2024SE |
| K231799 | INERTIA® CONNEXX Modular Pedicle Screw SystemNKB · Special | 07/20/2023SE |
| K221905 | INERTIA CONNEXX Modular Pedicle Screw SystemNKB · Special | 07/28/2022SE |
| K202230 | NEXXT MATRIXX Stand Alone ALIF SystemOVD · Traditional | 12/15/2020SE |
| K202192 | STRUXXURE®-L and STRUXXURE®-A Plate SystemKWQ · Traditional | 09/17/2020SE |
| K200969 | NEXXT MATRIXX SystemMAX · Special | 05/21/2020SE |
| K200543 | NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemOVE · Special | 03/23/2020SE |
| K193412 | NEXXT MATRIXX SystemPLR · Traditional | 02/24/2020SE |
| K193370 | Nexxt Matrixx SystemMAX · Special | 01/21/2020SE |
Questions and answers
When was NEXXT SPINE NAVIGATION System cleared by the FDA?
NEXXT SPINE NAVIGATION System (K220291) received a 510(k) decision of Substantially Equivalent on March 31, 2022, 58 days after the submission was received.
What is the product code of K220291?
The FDA product code is OLO – Orthopedic Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.