The following data is part of a premarket notification filed by Brainlab Ag with the FDA for Brainlab Trauma.
| Device ID | K110204 |
| 510k Number | K110204 |
| Device Name: | BRAINLAB TRAUMA |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | BRAINLAB AG KAPELLENSTRASSE 12 Feldkirchen, DE 85622 |
| Contact | Alexander Schwiersch |
| Correspondent | Alexander Schwiersch BRAINLAB AG KAPELLENSTRASSE 12 Feldkirchen, DE 85622 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-01-24 |
| Decision Date | 2011-08-05 |
| Summary: | summary |