Product areas
FDA product code distribution
Brainlab AG
Country / Region:United States (US)Website:brainlab.com
510(k) submissions
8 total
Showing 1–8
| K number | Device name | Product code | Class | Decision |
|---|---|---|---|---|
| K252562 | Spine & Trauma Navigation Instruments | OLO | Class 2 | 2025-09-12 |
| K240701 | Drill Guide; Drill Bit; Spine & Trauma Navigation | OLO | Class 2 | 2024-05-23 |
| K234047 | Automatic Registration | OLO | Class 2 | 2024-03-20 |
| K223553 | Spine Planning (2.0), Elements Spine Planning, Elements Planning Spine | OLO | Class 2 | 2023-08-02 |
| K222966 | Cirq Arm System (2.0);Alignment System Spine | OLO | Class 2 | 2022-10-27 |
| K221618 | Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma, Alignment System Spine, Alignment Software Spine, Cirq Arm System | OLO | Class 2 | 2022-08-30 |
| K220652 | Knee 3 | OLO | Class 2 | 2022-06-03 |
| K212245 | Spine and Trauma Navigation System, Spine & Trauma 3D Navigation, Instrument Selection, Fluoro 3D, Registration Software Fluoro 3D, Registration Software Paired Point, Registration Software Spine Surface Matching, Spine Planning, Elements Screw Planning Spine, Elements Spine Screw Planning | OLO | Class 2 | 2022-04-13 |
Company profile
- Canonical name
- Brainlab AG
- Country / Region
- United States(US)
- Address
- Olof-Palme-Str 9 Munich, DE 81829
- Website
- brainlab.com
Predicate manufacturers
Companies whose devices this company cited as predicates
1 manufacturers
- 5
Citing manufacturers
Companies that cited this company's devices as predicates
3 manufacturers
- 5
- 3
- 2