The following data is part of a premarket notification filed by Brainlab Ag with the FDA for Spine & Trauma Ict.
| Device ID | K083310 |
| 510k Number | K083310 |
| Device Name: | SPINE & TRAUMA ICT |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | BRAINLAB AG KAPELLENSTRASSE 12 Feldkirchen, DE 85622 |
| Contact | Rainer Birkenbach |
| Correspondent | Rainer Birkenbach BRAINLAB AG KAPELLENSTRASSE 12 Feldkirchen, DE 85622 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-10 |
| Decision Date | 2009-04-01 |
| Summary: | summary |