Recognized a 510(k)/PMA number — showing its clearance record and devices.
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Navigation Software Spine & Trauma 3D | 2.5 | Brainlab SE | HAW | 04056481000714 |
| Drill Guide Tube 2.4 150 Mm | 41839-27 | Brainlab SE | HAW | 04056481100100 |
| Igs Handle Softgrip 'Universal' | 55830-15 | Brainlab SE | HAW | 04056481001285 |
| Spine Reference X-Clamp Size L | 55752 | Brainlab SE | HAW | 04056481005221 |
| Spine Probe Tip Set - Thoracic | 55833 | Brainlab SE | HAW | 04056481005146 |
| Radiolucent Spine Reference Clamp | 55756C | Brainlab SE | HAW | 04056481001605 |
| Drill Guide Tube 6.0 X 142 Mm Tfs | 41839-55 | Brainlab SE | HAW | 04056481003401 |
| Spine Reference X-Clamp Size S | 55751 | Brainlab SE | HAW | 04056481005238 |
| Igs Handle Softgrip 'Gearshift' | 55830-10A | Brainlab SE | HAW | 04056481001308 |
| Bone Fixator 1-Pin, X-Press Size-M | 52422A | Brainlab SE | HAW | 04056481002367 |
| Calibration Insert Spinal Probe 3.62Mm | 53520 | Brainlab SE | HAW | 04056481005481 |
| Refl. Marker Disks (Single Use, 3 Pcs) | 55760-03 | Brainlab SE | HAW | 04056481001582 |
| Scanner Reference Adapter Bodytom | 19134-10 | Brainlab SE | HAW | 04056481004668 |
| Calibration Adapter Siemens 3D C-Arm | 22785 | Brainlab SE | HAW | 04056481006310 |
| Ziehm Fd 2D Calibration Plate | 55736 | Brainlab SE | HAW | 04056481005252 |
| Navigation Software Spine & Trauma 3D | 2.1 | Brainlab SE | HAW | 04056481000721 |
| Spine Probe Tip Set - Lumbar | 55834 | Brainlab SE | HAW | 04056481005139 |
| Igs Probe 5.5Mm Ulrich Tangors | 55830-64 | Brainlab SE | HAW | 04056481001148 |
| Igs Awl Ulrich Tango Rs | 55830-60A | Brainlab SE | HAW | 04056481001155 |
| Igs Probe 7.5Mm Ulrich Tangors | 55830-66 | Brainlab SE | HAW | 04056481001124 |
| Fluoro Registration Kit (Rev.1) | 41705A | Brainlab SE | HAW | 04056481003883 |
| Bl Pointer, Sharp-Tip-Extended | 52780 | Brainlab SE | HAW | 04056481005795 |
| Igs Probe 6.5Mm Ulrich Tangors | 55830-65 | Brainlab SE | HAW | 04056481001131 |