Curiteva Navigation System
FDA 510(k) K223200 · Curiteva, Inc.
510(k) numberK223200
Submission
- Device name
- Curiteva Navigation System
- Applicant
- Curiteva, Inc.
Tanner, AL, US - Received
- October 13, 2022
- Decision date
- January 6, 2023
- 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 |
|---|---|---|
| K252205 | Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…ODP · Traditional | 01/16/2026SE |
| K254061 | Curiteva Porous PEEK Cervical Interbody Fusion SystemODP · Special | 01/15/2026SE |
| K250845 | Curiteva Porous PEEK Standalone ALIF SystemOVD · Traditional | 06/18/2025SE |
| K243137 | Curiteva Porous PEEK Laminoplasty SystemNQW · Special | 10/28/2024SE |
| K233360 | Curiteva Thoracolumbar Plate SystemKWQ · Traditional | 02/29/2024SE |
| K233744 | Curiteva Porous PEEK Lumbar Interbody Fusion SystemMAX · Traditional | 01/18/2024SE |
| K231232 | Curiteva Laminoplasty SystemNQW · Traditional | 06/28/2023SE |
| K213030 | Curiteva Porous PEEK Cervical Interbody Fusion SystemODP · Traditional | 02/13/2023SE |
| K210402 | Curiteva Sacroiliac Joint Fusion SystemOUR · Traditional | 09/09/2021SE |
| K191810 | Curiteva Pedicle Screw SystemNKB · Traditional | 08/28/2019SE |
Questions and answers
When was Curiteva Navigation System cleared by the FDA?
Curiteva Navigation System (K223200) received a 510(k) decision of Substantially Equivalent on January 6, 2023, 85 days after the submission was received.
What is the product code of K223200?
The FDA product code is OLO – Orthopedic Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.