Renaissance
FDA 510(k) K120812 · Mazor Robotics , Ltd.
510(k) numberK120812
Submission
- Device name
- Renaissance
- Applicant
- Mazor Robotics , Ltd.
Kfar Saba, IL - Received
- March 16, 2012
- Decision date
- July 12, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code HAW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253856 | Geniant Cranial (Navigated Neurosurgical Positioning Robot)HAW · Traditional | Koh Young Technology, Inc. | 09/10/2026SE |
| K261932 | Leksell® Vantage Stereotactic SystemHAW · Traditional | Elekta Solutions AB | 08/05/2026SE |
| K253663 | Zeta Navigation SystemHAW · Traditional | Zeta Surgical, Inc. | 05/01/2026SE |
| K253379 | Stealth AXiS Cranial clinical applicationHAW · Traditional | Medtronic Navigation, Inc. | 03/26/2026SE |
| K231897 | NeuroAlign softwareHAW · Traditional | Medivis, Inc. | 10/21/2025SE |
| K251317 | SOLOPASS 2.0 SystemHAW · Traditional | Intravent Medical Partners | 09/05/2025SE |
| K250893 | Ball Joint Guide Array (66295)HAW · Traditional | Bayer Medical Care, Inc. | 09/04/2025SE |
| K250505 | Ez-FiducialsHAW · Traditional | Phasor Health, LLC | 07/09/2025SE |
| K242575 | Stereotaxic Guiding Surgical Devices, NaoTrac SHAW · Traditional | Brain Navi Biotechnology Co., Ltd. | 05/23/2025SE |
| K241327 | Navient Image Guide Navigation System (955-NC-NC), CranialHAW · Traditional | Claronav | 02/05/2025SE |
More from Claronav
| 510(k) | Device | Decision |
|---|---|---|
| K251316 | Mazor X System / Mazor X Stealth EditionOLO · Traditional | 09/11/2025SE |
| K230064 | Mazor X System (Mazor X Stealth Edition)OLO · Traditional | 04/07/2023SE |
| K203005 | Mazor XOLO · Special | 10/27/2020SE |
| K200935 | Mazor XOLO · Special | 05/08/2020SE |
| K182077 | Mazor X System (Mazor X Stealth Edition)OLO · Traditional | 11/02/2018SE |
| K180307 | Mazor XOLO · Special | 04/30/2018SE |
| K172522 | Mazor XOLO · Special | 09/15/2017SE |
| K163221 | Mazor XOLO · Traditional | 04/04/2017SE |
| K152041 | Renaissance X SystemOLO · Special | 11/17/2015SE |
| K140167 | Renaissance X SystemOLO · Traditional | 09/10/2014SE |
Questions and answers
When was Renaissance cleared by the FDA?
Renaissance (K120812) received a 510(k) decision of Substantially Equivalent on July 12, 2012, 118 days after the submission was received.
What is the product code of K120812?
The FDA product code is HAW – Neurological Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.