AnyPlus Navigated Instruments System
FDA 510(k) K243073 · GS Medical Co., Ltd.
510(k) numberK243073
Submission
- Device name
- AnyPlus Navigated Instruments System
- Applicant
- GS Medical Co., Ltd.
Cheongju-Si, KR - Received
- September 27, 2024
- Decision date
- December 6, 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 |
|---|---|---|
| K241738 | PYXIS 3D Titanium Cervical Cage systemODP · Traditional | 08/20/2024SE |
| K240350 | AnyPlus II Spinal Fixation SystemNKB · Traditional | 04/03/2024SE |
| K231808 | QUASAR Standalone ACIF SystemOVE · Special | 07/20/2023SE |
| K223868 | PYXIS 3D Titanium Cage SystemMAX · Traditional | 04/26/2023SE |
| K222041 | CYGNUS-C Standalone ACIF SystemOVE · Traditional | 02/09/2023SE |
| K221687 | Pegasus-X Expandable PLIF SystemMAX · Traditional | 07/27/2022SE |
| K211797 | TRACKER Plus Kyphoplasty SystemNDN · Traditional | 10/28/2021SE |
| K200592 | GS Medical AnyPlus PEEK Cage SystemODP · Traditional | 08/10/2020SE |
| K192335 | TRACKER Kyphoplasty SystemNDN · Traditional | 12/04/2019SE |
| K190170 | MVP Cervical Plate SystemKWQ · Traditional | 05/13/2019SE |
Questions and answers
When was AnyPlus Navigated Instruments System cleared by the FDA?
AnyPlus Navigated Instruments System (K243073) received a 510(k) decision of Substantially Equivalent on December 6, 2024, 70 days after the submission was received.
What is the product code of K243073?
The FDA product code is OLO – Orthopedic Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.