The following data is part of a premarket notification filed by Brainlab Ag with the FDA for Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma, Alignment System Spine, Alignment Software Spine, Cirq Arm System.
| Device ID | K221618 |
| 510k Number | K221618 |
| Device Name: | Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma, Alignment System Spine, Alignment Software Spine, Cirq Arm System |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | Brainlab AG Olof-Palme-Str.9 Munich, DE 81829 |
| Contact | Chiara Cunico |
| Correspondent | Chiara Cunico Brainlab AG Olof-Palme-Str.9 Munich, DE 81829 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-06-03 |
| Decision Date | 2022-08-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056481144470 | K221618 | 000 |
| 04056481145866 | K221618 | 000 |
| 04056481145859 | K221618 | 000 |
| 04056481145842 | K221618 | 000 |