Harvey(R) Surgical Assistant
FDA 510(k) K200892 · Orthalign, Inc.
510(k) numberK200892
Submission
- Device name
- Harvey(R) Surgical Assistant
- Applicant
- Orthalign, Inc.
Aliso Viejo, CA, US - Received
- April 3, 2020
- Decision date
- June 18, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K262253 | Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03)ONN · Special | 07/31/2026SE |
| K253507 | Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, KneeONN · Traditional | 06/02/2026SE |
| K242616 | Lantern® HipONN · Special | 10/03/2024SE |
| K200642 | OrthAlign Plus SystemOLO · Special | 04/10/2020SE |
| K172462 | OrthAlign Plus SystemOLO · Traditional | 11/22/2017SE |
| K171780 | OrthAlign Plus SystemOLO · Special | 07/11/2017SE |
| K163379 | KneeAlign 2 SystemOLO · Traditional | 03/02/2017SE |
| K162962 | OrthAlign Plus SystemOLO · Traditional | 01/23/2017SE |
| K153237 | OrthAlign Plus SystemOLO · Traditional | 03/01/2016SE |
| K140331 | Orthalign Plus SystemOLO · Traditional | 06/10/2014SE |
Questions and answers
When was Harvey(R) Surgical Assistant cleared by the FDA?
Harvey(R) Surgical Assistant (K200892) received a 510(k) decision of Substantially Equivalent on June 18, 2020, 76 days after the submission was received.
What is the product code of K200892?
The FDA product code is OLO – Orthopedic Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.