ORR
2018-11-02
Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri
FDA product code ORR · 4 cleared devices
Class 2
Neurology
- Regulation
- 21 CFR 882.4560
- Review panel
- NE
- Implant
- No
- Life sustaining
- No
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 2010-06-16 – 2018-11-02
To aid the surgeon in planning and conducting general stereotactic neurosurgery in an MRI suite.
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