Zavation Navigation Instrument System
FDA 510(k) K223808 · Zavation Medical Products, LLC
510(k) numberK223808
Submission
- Device name
- Zavation Navigation Instrument System
- Applicant
- Zavation Medical Products, LLC
Flowood, MS, US - Received
- December 20, 2022
- Decision date
- July 12, 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 |
|---|---|---|
| K253943 | Tiger 2 SystemNKB · Traditional | 07/24/2026SE |
| K243908 | Tiger 2 SystemNKB · Traditional | 02/03/2025SE |
| K233509 | Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…MAX · Traditional | 04/10/2024SE |
| K231811 | Zavation Connector SystemNKB · Traditional | 08/22/2023SE |
| K230731 | Zavation ALIF SystemOVD · Traditional | 06/14/2023SE |
| K221726 | Uni-FuZe-C Bone StripMQV · Traditional | 01/18/2023SE |
| K222614 | Zavation Spinal SystemNKB · Traditional | 12/05/2022SE |
| K221049 | Zavation VariSync Plate System and VariSync Spacer SystemOVE · Traditional | 08/12/2022SE |
| K220581 | Zavation eZspand Interbody SystemMAX · Traditional | 06/02/2022SE |
| K212811 | Ti3Z Lumbar Interbody SystemMAX · Traditional | 04/12/2022SE |
Questions and answers
When was Zavation Navigation Instrument System cleared by the FDA?
Zavation Navigation Instrument System (K223808) received a 510(k) decision of Substantially Equivalent on July 12, 2023, 204 days after the submission was received.
What is the product code of K223808?
The FDA product code is OLO – Orthopedic Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.