510(k) K120812
K120812 is an FDA 510(k) premarket notification submitted by Mazor Robotics , Ltd. for the device "RENAISSANCE". The FDA issued a decision of Substantially Equivalent on Jul 12, 2012. The device falls under product code HAW (Neurological Stereotaxic Instrument), a Class II device regulated under 21 CFR 882.4560. Mazor Robotics , Ltd. has 12 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 12, 2012
- Date Received
- Mar 16, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Neurological Stereotaxic Instrument
- Device Class
- Class II
- Regulation Number
- 882.4560
- Review Panel
- NE
- Submission Type
- 510(k)