The following data is part of a premarket notification filed by Brainlab Ag with the FDA for 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 Plann.
| Device ID | K212245 |
| 510k Number | K212245 |
| Device Name: | 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 Plann |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | Brainlab AG Olof-Palme-Str. 9 Munich, DE 81829 |
| Contact | Chiara Cunico |
| Correspondent | Chiara Cunico Brainlab AG Olof-Palme-Str. 9 Munich, DE 81829 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-19 |
| Decision Date | 2022-04-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056481143244 | K212245 | 000 |
| 04056481142728 | K212245 | 000 |
| 04056481142742 | K212245 | 000 |
| 04056481143114 | K212245 | 000 |
| 04056481143176 | K212245 | 000 |
| 04056481143183 | K212245 | 000 |
| 04056481143190 | K212245 | 000 |
| 04056481143206 | K212245 | 000 |
| 04056481143213 | K212245 | 000 |
| 04056481143220 | K212245 | 000 |
| 04056481143237 | K212245 | 000 |
| 04056481143954 | K212245 | 000 |