Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial, Cirq Robotic Alignment Module, Cirq Robotic Alignment Cranial And Spine, CIRQ Robotic Alignment Cranial and Spine System
FDA 510(k) clearance K210989 · decided 2021-11-12
Clearance details
- K-number
- K210989
- Device name
- Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial, Cirq Robotic Alignment Module, Cirq Robotic Alignment Cranial And Spine, CIRQ Robotic Alignment Cranial and Spine System
- Applicant
- Brainlab AG
- Decision
- Substantially Equivalent
- Date received
- 2021-04-02
- Decision date
- 2021-11-12
- Days to decision
- 224 days
- Clearance type
- Traditional
- Product code
- HAW
- Device class
- 2
- Regulation number
- 882.4560
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Munich, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.