VERTICALE Navigation Instruments
FDA 510(k) K212007 · Silony Medical GmbH
510(k) numberK212007
Submission
- Device name
- VERTICALE Navigation Instruments
- Applicant
- Silony Medical GmbH
Leinfelden-Echterdingen, DE - Received
- June 28, 2021
- Decision date
- August 12, 2021
- 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 |
|---|---|---|
| K253921 | VERTICALE® Navigation InstrumentsOLO · Traditional | 06/26/2026SE |
| K254148 | VERTICALE GPS InstrumentsOLO · Traditional | 02/19/2026SE |
| K223806 | VERTICALE® Triangular Fixation SystemNKB · Traditional | 07/06/2023SE |
| K223649 | VERTICALE® Navigation InstrumentsOLO · Special | 12/22/2022SE |
| K192013 | VERTICALE® Cervical SystemNKG · Traditional | 04/07/2020SE |
| K190680 | Favo S-TlifMAX · Traditional | 07/18/2019SE |
| K182608 | Oyster ACIF CageODP · Traditional | 06/13/2019SE |
| K181899 | Roccia® PlifMAX · Traditional | 12/13/2018SE |
| K180963 | Roccia Alif, Roccia TlifMAX · Traditional | 07/11/2018SE |
| K171421 | VERTICALE® Posterior Spinal Fixation System/VERTICALE® SystemNKB · Traditional | 01/10/2018SE |
Questions and answers
When was VERTICALE Navigation Instruments cleared by the FDA?
VERTICALE Navigation Instruments (K212007) received a 510(k) decision of Substantially Equivalent on August 12, 2021, 45 days after the submission was received.
What is the product code of K212007?
The FDA product code is OLO – Orthopedic Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.