K202320 is an FDA 510(k) clearance for the CIRQ Robotic Alignment Module, Cirq, Cirq Robotic Alignment Module Spinal, Cirq Robotic Alignment Cranial and Spine, CIRQ Robotic Alignment Cranial and Spine System. This device is classified as a Orthopedic Stereotaxic Instrument (Class II - Special Controls, product code OLO).
Submitted by Brainlab AG (Munich, DE). The FDA issued a Cleared decision on December 23, 2020, 128 days after receiving the submission on August 17, 2020.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 882.4560. Stereotaxic Guidance During Orthopedic Surgery Procedures. Indicated For Orthopedic Joint Or Spine Surgery. Neurological Stereotaxic Instruments Are Classified Under Product Code Haw..
| 510(k) Number | K202320 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 17, 2020 |
| Decision Date | December 23, 2020 |
| Days to Decision | 128 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | OLO — Orthopedic Stereotaxic Instrument |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4560 |
| Definition | Stereotaxic Guidance During Orthopedic Surgery Procedures. Indicated For Orthopedic Joint Or Spine Surgery. Neurological Stereotaxic Instruments Are Classified Under Product Code Haw. |