Spine & Trauma Navigation
- Primary DI
- 04056481143954
- Brand
- Spine & Trauma Navigation
- Company
- Brainlab SE
- Model
- 2.0
- Device description
- Spine & Trauma Navigation is intended as an intraoperative image-guided localization system to enable open and minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient's preoperative or intraoperative 2D or 3D image data.Spine & Trauma Navigation enables computer-assisted navigation of medical image data, which can either be acquired preoperatively or intraoperatively by an appropriate image acquisition system. The software offers screw and interbody device planning and navigation with surgical instruments.The system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, the pelvis, a long bone or vertebra can be identified relative to the acquired image (CT, MR, 3D fluoroscopic image reconstruction or 2D fluoroscopic image) and/or an image data based model of the anatomy.
- Published
- 2022-05-31
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
Product Codes#
| Code | Name |
|---|---|
| OLO | Orthopedic Stereotaxic Instrument |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| OLO | Orthopedic Stereotaxic Instrument | Neurology | 2 |
Premarket Submissions#
Premarket Details#
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|---|---|---|---|---|
| K212245 | 000 | 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 | Brainlab AG | 2022-04-13 | OLO |
| K221618 | 000 | Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma, Alignment System Spine, Alignment Software Spine, Cirq Arm System | Brainlab AG | 2022-08-30 | OLO |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 04056481143954 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 04056481143954 | 04056481143954 | 4056481143954 |
GMDN Terms#
| Term | Definition |
|---|---|
| Electromagnetic/optical surgical navigation device tracking system | A mobile assembly of mains electricity (AC-powered) devices intended to provide a physician with both electromagnetic (EM) and optical tools to track manual surgical instruments and locate target anatomical structures with respect to pre-acquired images (e.g., CT/MRI scan) or real-time data [e.g., endoscopic, ultrasound (US)] during computer assisted surgery (CAS). It consists of a workstation with controls/display, an EM field generator, a camera, and sensors/localizers for attachment to the patient and instruments for position/movement tracking. It is used for multiple procedures (e.g., craniotomy) in various fields [e.g., ear/nose/throat (ENT), craniomaxillofacial (CMF) surgery]. |
Sterilization Methods#
| Method |
|---|
Regulatory Flags#
- DUNS number
- 314482980
- Device count
- 1
- Lot or batch
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 04056481122751 | Sterilization Tray Standards Cranial Accessories | 52315 | 2020-10-21 | |
| 04056481122867 | Sterilization Tray Frameless Biopsy System | 52304 | 2020-10-21 | |
| 04056481122874 | Sterilization Tray Varioguide | 52303 | 2020-10-21 | |
| 04056481095406 | STERILIZATION TRAY SPINE BASIC/ANT/UNIV | 52306A | 52306A | 2020-04-02 |
| 04056481122812 | STERILIZATION TRAY HIP REPLACEMENT | 52309 | 52309 | 2020-04-02 |
| 04056481122904 | Sterilization Tray Trauma / Knee Arthroscopy | 52300 | 2020-01-31 | |
| 04056481122805 | Sterilization Tray Hip Resurfacing | 52310 | 52310 | 2019-09-27 |
| 04056481004835 | Em Sterilization Tray Basic Instruments | 18099-08A | 18099-08A | 2016-09-15 |
| 04056481002718 | Headband Reference Star - Connector | 41877-10 | 41877-10 | 2016-09-15 |
| 04056481003715 | Mscope Adapter Hs/Moeller Hi-R 700/1000 | 41767-85 | 41767-85 | 2016-09-15 |
| 04056481141363 | CRANIAL 4PI CT TABLE OVERLAY | 43430 | 2022-05-31 | |
| 04056481006884 | ELEMENTS LEAD LOCALIZATION | 1.0 | 26338-02 | 2016-11-18 |
| 04056481131920 | Registr. Matrix Imri Ge Headholder | 19202C | 19202C | 2016-09-17 |
| 04056481143985 | Mixed Reality Spine Navigation | 1.0 | 2025-05-31 | |
| 04056481144609 | ExacTrac Dynamic | 2.0 | 2025-02-19 | |
| 04056481144654 | Viewer 5.4 | 5.4 | 2024-11-05 | |
| 04056481004101 | Target Positioner Leksell | 40700-20A | 40700-20A | 2016-09-15 |
| 04056481006525 | Em Disposable Stylet | 18097 | 18097 | 2018-02-08 |
| 04056481138769 | Elements Trajectory Planning | 2.0 | 26250-02C | 2017-06-14 |
| 04056481141981 | HIP7 | 7.0 | 2020-06-08 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 00840493423166 | RIVA Pedicle Screw System | XENIX MEDICAL LLC | OLO | 2026-06-08 |
| 00840493423173 | RIVA Pedicle Screw System | XENIX MEDICAL LLC | OLO | 2026-06-08 |
| 00840493423180 | RIVA Pedicle Screw System | XENIX MEDICAL LLC | OLO | 2026-06-08 |
| 00840493423197 | RIVA Pedicle Screw System | XENIX MEDICAL LLC | OLO | 2026-06-08 |
| 00840493423203 | RIVA Pedicle Screw System | XENIX MEDICAL LLC | OLO | 2026-06-08 |
| 00840493423210 | RIVA Pedicle Screw System | XENIX MEDICAL LLC | OLO | 2026-06-08 |
| 00840493423227 | RIVA Pedicle Screw System | XENIX MEDICAL LLC | OLO | 2026-06-08 |
| 00840493423234 | RIVA Pedicle Screw System | XENIX MEDICAL LLC | OLO | 2026-06-08 |
| 00840493423241 | RIVA Pedicle Screw System | XENIX MEDICAL LLC | OLO | 2026-06-08 |
| 00840493423258 | RIVA Pedicle Screw System | XENIX MEDICAL LLC | OLO | 2026-06-08 |
| 00840493423265 | RIVA Pedicle Screw System | XENIX MEDICAL LLC | OLO | 2026-06-08 |
| 00840493423272 | RIVA Pedicle Screw System | XENIX MEDICAL LLC | OLO | 2026-06-08 |
| 00840493423289 | RIVA Pedicle Screw System | XENIX MEDICAL LLC | OLO | 2026-06-08 |
| 00840493423296 | RIVA Pedicle Screw System | XENIX MEDICAL LLC | OLO | 2026-06-08 |
| 00840493423302 | RIVA Pedicle Screw System | XENIX MEDICAL LLC | OLO | 2026-06-08 |
| 00840493423319 | RIVA Pedicle Screw System | XENIX MEDICAL LLC | OLO | 2026-06-08 |
| 00840493423326 | RIVA Pedicle Screw System | XENIX MEDICAL LLC | OLO | 2026-06-08 |
| 00840493423333 | RIVA Pedicle Screw System | XENIX MEDICAL LLC | OLO | 2026-06-08 |
| 00840493423340 | RIVA Pedicle Screw System | XENIX MEDICAL LLC | OLO | 2026-06-08 |
| 00840493423357 | RIVA Pedicle Screw System | XENIX MEDICAL LLC | OLO | 2026-06-08 |
| 00840493423364 | RIVA Pedicle Screw System | XENIX MEDICAL LLC | OLO | 2026-06-08 |
| 00840493423371 | RIVA Pedicle Screw System | XENIX MEDICAL LLC | OLO | 2026-06-08 |
| 00840493423388 | RIVA Pedicle Screw System | XENIX MEDICAL LLC | OLO | 2026-06-08 |
| 00840493423395 | RIVA Pedicle Screw System | XENIX MEDICAL LLC | OLO | 2026-06-08 |
| 00840493423401 | RIVA Pedicle Screw System | XENIX MEDICAL LLC | OLO | 2026-06-08 |
| 00840493423418 | RIVA Pedicle Screw System | XENIX MEDICAL LLC | OLO | 2026-06-08 |
| 00840493423425 | RIVA Pedicle Screw System | XENIX MEDICAL LLC | OLO | 2026-06-08 |
| 00840493423432 | RIVA Pedicle Screw System | XENIX MEDICAL LLC | OLO | 2026-06-08 |
| 00840493423449 | RIVA Pedicle Screw System | XENIX MEDICAL LLC | OLO | 2026-06-08 |
| 00840493423456 | RIVA Pedicle Screw System | XENIX MEDICAL LLC | OLO | 2026-06-08 |