The following data is part of a premarket notification filed by Brainlab Ag with the FDA for Cirq Arm System (2.0);alignment System Spine.
| Device ID | K222966 |
| 510k Number | K222966 |
| Device Name: | Cirq Arm System (2.0);Alignment System Spine |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | Brainlab AG Olof-Palme-Str. 9 Munich, DE 81829 |
| Contact | Sadwini Suresh |
| Correspondent | Sadwini Suresh Brainlab AG Olof-Palme-Str. 9 Munich, DE 81829 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-09-27 |
| Decision Date | 2022-10-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056481143961 | K222966 | 000 |