DeGen Navigated Instrumentation
FDA 510(k) K213918 · Degen Medical
510(k) numberK213918
Submission
- Device name
- DeGen Navigated Instrumentation
- Applicant
- Degen Medical
Florence, SC, US - Received
- December 15, 2021
- Decision date
- February 9, 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 |
|---|---|---|
| K251829 | DeGen Medical Patient Specific Implant (PSI) SystemOVD · Traditional | 12/08/2025SE |
| K252737 | DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemODP · Traditional | 10/10/2025SE |
| K250667 | DeGen Medical Patient Specific Implant (PSI) SystemMAX · Special | 04/04/2025SE |
| K241077 | DeGen Medical Patient Specific Implant (PSI) SystemOVD · Traditional | 10/29/2024SE |
| K240326 | Solar Lumbar Interbody Fusion SystemMAX · Traditional | 07/29/2024SE |
| K231199 | Solar Lumbar Interbody Fusion SystemMAX · Traditional | 06/16/2023SE |
| K223418 | DeGen Impulse AM SystemMAX · Traditional | 03/17/2023SE |
| K213901 | Cyclops Anterior Cervical Plate SystemKWQ · Special | 01/07/2022SE |
| K210090 | Impulse AM Interbody Fusion SystemMAX · Traditional | 08/30/2021SE |
| K203816 | DeGen Navigated InstrumentationOLO · Traditional | 04/02/2021SE |
Questions and answers
When was DeGen Navigated Instrumentation cleared by the FDA?
DeGen Navigated Instrumentation (K213918) received a 510(k) decision of Substantially Equivalent on February 9, 2022, 56 days after the submission was received.
What is the product code of K213918?
The FDA product code is OLO – Orthopedic Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.