Navigated Spine Instruments
FDA 510(k) K203205 · Stryker Spine
510(k) numberK203205
Submission
- Device name
- Navigated Spine Instruments
- Applicant
- Stryker Spine
Leesburg, VA, US - Received
- October 30, 2020
- Decision date
- March 23, 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 |
|---|---|---|
| K262061 | Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…ODP · Special | 07/17/2026SE |
| K261008 | Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive…MQV · Special | 04/24/2026SE |
| K242361 | OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…KWQ · Traditional | 11/07/2024SE |
| K242280 | Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip, Vitoss® BiModal Bioactive…MQV · Special | 08/29/2024SE |
| K222684 | XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…NKB · Traditional | 06/08/2023SE |
| K221490 | Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…ODP · Traditional | 02/14/2023SE |
| K200666 | Stryker Xia 3 Power AdaptorNKB · Special | 04/23/2020SE |
| K183249 | Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…MAX · Traditional | 07/25/2019SE |
| K183071 | VLIFT-s Vertebral Body Replacement SystemPLR · Special | 01/10/2019SE |
| K181014 | Tritanium PL CageMAX · Traditional | 07/18/2018SE |
Questions and answers
When was Navigated Spine Instruments cleared by the FDA?
Navigated Spine Instruments (K203205) received a 510(k) decision of Substantially Equivalent on March 23, 2021, 144 days after the submission was received.
What is the product code of K203205?
The FDA product code is OLO – Orthopedic Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.