EGPS Navigated Instruments
FDA 510(k) K240160 · Astura Medical
510(k) numberK240160
Submission
- Device name
- EGPS Navigated Instruments
- Applicant
- Astura Medical
Irving, TX, US - Received
- January 19, 2024
- Decision date
- October 17, 2024
- 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 |
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|---|---|---|
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| K243259 | MASADA Modular Spinal Fixation SystemNKB · Traditional | 01/07/2025SE |
| K233359 | DOMINION Expandable Corpectomy SystemMQP · Traditional | 03/08/2024SE |
| K231694 | MASADA Modular Spinal Fixation SystemNKB · Traditional | 11/16/2023SE |
| K232211 | REUNION Sacroiliac Joint Fusion SystemOUR · Traditional | 10/24/2023SE |
| K223335 | SIRION Lateral Lumbar Interbody SystemMAX · Traditional | 05/09/2023SE |
| K222097 | OLYMPIC Deformity Band SystemOWI · Traditional | 05/04/2023SE |
| K222554 | EL CAPITAN Anterior Lumbar Interbody FusionOVD · Traditional | 01/19/2023SE |
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Questions and answers
When was EGPS Navigated Instruments cleared by the FDA?
EGPS Navigated Instruments (K240160) received a 510(k) decision of Substantially Equivalent on October 17, 2024, 272 days after the submission was received.
What is the product code of K240160?
The FDA product code is OLO – Orthopedic Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.