Brainlab Trauma
by Brainlab AG
510(k) K110204
Brainlab Trauma is a Class II device made by Brainlab AG, cleared under FDA 510(k) K110204 on 5 Aug 2011, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK110204 | Date5 Aug 2011 | StatusActive |
Official records
- FDA 510(k) database K110204
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- OLO
- Device class
- Class II
- Regulation
- 21 CFR Part 882.4560
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K110204
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Calibration Insert F Synthes Lfn 12-16Mm 53512 | 53512 / 53512 | 04056481005498 | No longer on the market | |
| Calibration Insert F. Synthes Lfn 9-11Mm 53511 | 53511 / 53511 | 04056481005504 | No longer on the market | |
| Calibration Insert For Synthes Lcp/Liss 53510 | 53510 / 53510 | 04056481005511 | No longer on the market | |
| Drill Guide Kit - Ilio Sacral 41839-04 | 41839-04 / 41839-04 | 04056481003517 | No longer on the market | |
| Drill Guide Trocar Icm4 Insert 41839-99 | 41839-99 / 41839-99 | 04056481003265 | No longer on the market | |
| Drill Guide Tube 2.6 X 150 Mm 41839-60 | 41839-60 / 41839-60 | 04056481003395 | No longer on the market | |
| Drill Guide Tube 2.6 X 150 Mm Blunt 41839-66 | 41839-66 / 41839-66 | 04056481003371 | No longer on the market | |
| Drill Guide Tube 3.0 X 45 Mm 41839-25 | 41839-25 / 41839-25 | 04056481003487 | No longer on the market | |
| Drill Guide Tube 3.2 X 150 Mm 41839-30A | 41839-30A / 41839-30A | 04056481003463 | No longer on the market | |
| Drill Guide Tube 3.5 X 150 Mm 41839-85 | 41839-85 / 41839-85 | 04056481003302 | No longer on the market | |
| Drill Guide Tube 4.5 X 200 Mm 41839-40 | 41839-40 / 41839-40 | 04056481003432 | No longer on the market | |
| Fluoro Kit (Rev.2) 55705-10 | 55705-10 / 55705-10 | 04056481001643 | No longer on the market | |
| Icm Calibration Insert 6.3Mm 53521 | 53521 / 53521 | 04056481005474 | No longer on the market | |
| Implant Reference Array Angled 53500 | 53500 / 53500 | 04056481005528 | No longer on the market | |
| Navigation Software Fluoro Express 3.2 | 22082-01A / 3.2 | 04056481000509 | No longer on the market | |
| Navigation Software Fluoro Express 3.2 | 22084 / 3.2 | 04056481000738 | No longer on the market | |
| Navigation Software Fluoro Express 3.4 Installer | 3.4 | 04056481139018 | No longer on the market | |
| Navigation Software Fluoro Express Installer 3.3 | 22084-03B / 3.3 | 04056481137908 | On the market | |
| Navigation Software Spine & Trauma 2D Installer 3.3 | 22082-04 / 3.3 | 04056481137915 | No longer on the market | |
| Navigation Software Trauma 2D 3.1 | 22082 / 3.1 | 04056481000745 | No longer on the market |