Erisma LP Navigated Instruments
FDA 510(k) K202956 · Clariance, Sas
510(k) numberK202956
Submission
- Device name
- Erisma LP Navigated Instruments
- Applicant
- Clariance, Sas
Beaurains, FR - Received
- September 30, 2020
- Decision date
- February 26, 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 |
|---|---|---|
| K243904 | Elegance® Anterior Cervical plateKWQ · Special | 01/14/2025SE |
| K243670 | Idys® LIFMAX · Special | 12/31/2024SE |
| K241863 | Erisma® Lp Spinal Fixation System; Erisma® LP MISNKB · Special | 07/24/2024SE |
| K240872 | Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemNKB · Special | 04/26/2024SE |
| K240715 | Idys® C ZP 3DTiOVE · Special | 03/22/2024SE |
| K220182 | Aggeris-CKWQ · Traditional | 03/30/2022SE |
| K212562 | Idys-C ZP 3DTiOVE · Traditional | 10/12/2021SE |
| K200919 | Idys ALIF 3DTiMAX · Traditional | 04/12/2021SE |
| K202032 | Idys LLIF 3DTiOVD · Traditional | 04/01/2021SE |
| K200920 | Idys ALIF ZP 3DTiMAX · Special | 05/29/2020SE |
Questions and answers
When was Erisma LP Navigated Instruments cleared by the FDA?
Erisma LP Navigated Instruments (K202956) received a 510(k) decision of Substantially Equivalent on February 26, 2021, 149 days after the submission was received.
What is the product code of K202956?
The FDA product code is OLO – Orthopedic Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.