CROSSNAV Navigation Enabled Instruments
FDA 510(k) K233255 · DePuy Synthes
510(k) numberK233255
Submission
- Device name
- CROSSNAV Navigation Enabled Instruments
- Applicant
- DePuy Synthes
Oberdor, CH - Received
- September 28, 2023
- Decision date
- June 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 |
More from LEM Surgical AG
| 510(k) | Device | Decision |
|---|---|---|
| K233696 | DePuy Synthes Retrograde Femoral Nail Advanced SystemHSB · Traditional | 08/01/2024SE |
| K233256 | Robotic Integration InstrumentsOLO · Traditional | 06/17/2024SE |
| K233254 | TELIGEN System Navigation Ready InstrumentsOLO · Traditional | 06/14/2024SE |
| K233665 | DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment…HRS · Traditional | 03/21/2024SE |
| K231922 | DEPUY SYNTHES MAXFRAME AUTOSTRUT SystemKTT · Special | 07/26/2023SE |
| K221809 | DePuy Synthes 3.5mm Intrapelvic Acetabular SystemHRS · Traditional | 09/20/2022SE |
| K213563 | DePuy Synthes Radial Head Replacement SystemKWI · Traditional | 03/18/2022SE |
| K211051 | DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini Fragment LCP System)HRS · Traditional | 06/02/2021SE |
| K203414 | DePuy Synthes 2.7mm VA LCP Clavicle Plate System, DePuy Synthes 2.7mm VA LCP Clavicle…HRS · Special | 12/16/2020SE |
| K201959 | DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate SystemHRS · Traditional | 09/11/2020SE |
Questions and answers
When was CROSSNAV Navigation Enabled Instruments cleared by the FDA?
CROSSNAV Navigation Enabled Instruments (K233255) received a 510(k) decision of Substantially Equivalent on June 17, 2024, 263 days after the submission was received.
What is the product code of K233255?
The FDA product code is OLO – Orthopedic Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.