Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K110204
BRAINLAB TRAUMA · Brainlab AG · decided 2011-08-05 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Navigation Software Trauma 2D | 3.1 | Brainlab SE | OLO | 04056481000745 |
| Calibration Insert F Synthes Lfn 12-16Mm | 53512 | Brainlab SE | OLO | 04056481005498 |
| Drill Guide Tube 3.2 X 150 Mm | 41839-30A | Brainlab SE | OLO | 04056481003463 |
| Implant Reference Array Angled | 53500 | Brainlab SE | OLO | 04056481005528 |
| Drill Guide Tube 2.6 X 150 Mm Blunt | 41839-66 | Brainlab SE | OLO | 04056481003371 |
| Calibration Insert For Synthes Lcp/Liss | 53510 | Brainlab SE | OLO | 04056481005511 |
| Drill Guide Trocar Icm4 Insert | 41839-99 | Brainlab SE | OLO | 04056481003265 |
| Drill Guide Tube 4.5 X 200 Mm | 41839-40 | Brainlab SE | OLO | 04056481003432 |
| Drill Guide Kit - Ilio Sacral | 41839-04 | Brainlab SE | OLO | 04056481003517 |
| Navigation Software Fluoro Express | 3.2 | Brainlab SE | OLO | 04056481000509 |
| Navigation Software Fluoro Express | 3.2 | Brainlab SE | OLO | 04056481000738 |
| Navigation Software Fluoro Express 3.4 Installer | 3.4 | Brainlab SE | OLO | 04056481139018 |
| Icm Calibration Insert 6.3Mm | 53521 | Brainlab SE | OLO | 04056481005474 |
| Navigation Software Fluoro Express Installer | 3.3 | Brainlab SE | OLO | 04056481137908 |
| Drill Guide Tube 3.5 X 150 Mm | 41839-85 | Brainlab SE | OLO | 04056481003302 |
| Fluoro Kit (Rev.2) | 55705-10 | Brainlab SE | OLO | 04056481001643 |
| Drill Guide Tube 2.6 X 150 Mm | 41839-60 | Brainlab SE | OLO | 04056481003395 |
| Navigation Software Spine & Trauma 2D Installer | 3.3 | Brainlab SE | OLO | 04056481137915 |
| Drill Guide Tube 3.0 X 45 Mm | 41839-25 | Brainlab SE | OLO | 04056481003487 |
| Calibration Insert F. Synthes Lfn 9-11Mm | 53511 | Brainlab SE | OLO | 04056481005504 |