Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K210989
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 · Brainlab AG · decided 2021-11-12 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| DRILL BIT CRANIAL 3.4/3.8 | 56405-01A | Brainlab SE | HAW | 04056481143701 |
| Cirq Robotic Tracking Array Cranial 7.5 | 56402 | Brainlab SE | HAW | 04056481141561 |
| Cirq Robotic Instrument Holder Cranial | 56401 | Brainlab SE | HAW | 04056481141578 |
| Cirq Robotic Biopsy Guide Tube Cranial | 56403 | Brainlab SE | HAW | 04056481141585 |
| Cirq Robotic Biopsy Bone Anchor Cranial | 56404 | Brainlab SE | HAW | 04056481141592 |
| Cirq Robotic Biopsy Drill Bit 3.4 Cranial | 56405 | Brainlab SE | HAW | 04056481141608 |
| Cirq Robotic Depth Stop 3.4 mm Cranial | 56406 | Brainlab SE | HAW | 04056481141622 |
| DISPOSABLE KIT FOR CIRQ WITH ROBOTIC ALIGNMENT MODULE | 56101 | Brainlab SE | HAW OLO | 04056481141660 |
| Cirq Robotic Alignment Module | 56100 | Brainlab SE | HAW OLO | 04056481141646 |
| Cirq Robotic Disposable Kinematic Unit | 56102-01 | Brainlab SE | HAW OLO | 04056481144319 |
| DRILL DEPTH STOP CRANIAL 3.8 | 56406-38 | Brainlab SE | HAW | 04056481144388 |