The following data is part of a premarket notification filed by Brainlab Ag with the FDA for Cirq Robotic Alignment Module, Cirq, Cirq Robotic Alignment Module Spinal, Cirq Robotic Alignment Cranial And Spine, Cirq Robotic Alignment Cranial And Spine System.
| Device ID | K202320 |
| 510k Number | K202320 |
| Device Name: | CIRQ Robotic Alignment Module, Cirq, Cirq Robotic Alignment Module Spinal, Cirq Robotic Alignment Cranial And Spine, CIRQ Robotic Alignment Cranial And Spine System |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | Brainlab AG Olof-Palme-Str. 9 Munich, DE 80809 |
| Contact | Cunico Chiara |
| Correspondent | Cunico Chiara Brainlab AG Olof-Palme-Str. 9 Munich, DE 80809 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-17 |
| Decision Date | 2020-12-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056481141646 | K202320 | 000 |
| 04056481141233 | K202320 | 000 |
| 04056481141240 | K202320 | 000 |
| 04056481141257 | K202320 | 000 |
| 04056481141264 | K202320 | 000 |
| 04056481141271 | K202320 | 000 |
| 04056481141288 | K202320 | 000 |
| 04056481141295 | K202320 | 000 |
| 04056481141301 | K202320 | 000 |
| 04056481141318 | K202320 | 000 |
| 04056481141325 | K202320 | 000 |
| 04056481141332 | K202320 | 000 |
| 04056481141349 | K202320 | 000 |
| 04056481141660 | K202320 | 000 |