NuVasive Navigation.S Instruments
FDA 510(k) K200719 · Nu Vasive, Incorporated
510(k) numberK200719
Submission
- Device name
- NuVasive Navigation.S Instruments
- Applicant
- Nu Vasive, Incorporated
San Diego, CA, US - Received
- March 19, 2020
- Decision date
- December 2, 2020
- 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 |
|---|---|---|
| K231735 | NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…ODP · Special | 07/11/2023SE |
| K230894 | NuVasive Modulus ALIF SystemOVD · Traditional | 06/16/2023SE |
| K230989 | Rod Registration FrameOLO · Special | 05/05/2023SE |
| K223181 | NuVasive Reline SystemNKB · Traditional | 01/11/2023SE |
| K221751 | NuVasive Cohere ALIF System Intervertebral Body Fusion DeviceOVD · Traditional | 10/21/2022SE |
| K221388 | NuVasive Reline Cervical SystemNKG · Traditional | 09/09/2022SE |
| K220478 | NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemMAX · Traditional | 06/21/2022SE |
| K213654 | NuVasive Reline Cervical SystemNKG · Traditional | 02/23/2022SE |
| K203714 | NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System…MAX · Traditional | 12/23/2021SE |
| K212446 | NuVasive Anterior Cervical Plate SystemsKWQ · Traditional | 11/03/2021SE |
Questions and answers
When was NuVasive Navigation.S Instruments cleared by the FDA?
NuVasive Navigation.S Instruments (K200719) received a 510(k) decision of Substantially Equivalent on December 2, 2020, 258 days after the submission was received.
What is the product code of K200719?
The FDA product code is OLO – Orthopedic Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.