GLOBUS MEDICAL EXCELSIUS GPS

מדינה: סינגפור

שפה: אנגלית

מקור: HSA (Health Sciences Authority)

זמין מ:

GLOBUS MEDICAL SINGAPORE PTE. LTD.

סיווג:

Class C medical device

תוצרת:

GLOBUS MEDICAL INC

איזור תרפויטי:

Orthopaedics

סממני תרפויטית:

The ExcelsiusGPS® is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of instrument holders or tool guides to be used by surgeons for navigating or guiding standard surgical instruments in open or percutaneous procedures. The system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra can be identified relative to a CT-based model, fluoroscopy images, or digitized landmarks of the anatomy.

leaflet_short:

Device System Info:[System or Procedure Pack], [Sterile Medical Device], The Excelsius GPS is a robotic positioning system that includes a computer controlled robotic arm, instruments, and the accompanying 3D imaging software. Certain instruments are provided sterile (Radiation sterilized).; Models: Fixture, Fluoro Navigation, 9 in - 6143.2102, Fixture, Fluoro Navigation, 12 in - 6143.2103, End Effector, 15mm - 6143.2501, End Effector, 17mm - 6143.2502, Bone Clamp with Surveillance Marker, Medium - 6143.2508, Bone Clamp, with Surveillance Marker, Long - 6143.2509, Bone Clamp, with Surveillance Marker, Short - 6143.2510, Bone Clamp, Long - 6143.2511, Bone Clamp, Short - 6143.2512, Percutaneous Pin, Long - 6143.2513, Percutaneous Pin, Short - 6143.2514, Quattro Spike, Long - 6143.2515, Quattro Spike, Short - 6143.2516, Quattro Spike, Medium - 6143.2517, Low Profile Quattro Spike, Short - 6143.2518, Low Profile Quattro Spike, Long - 6143.2519, Dynamic Reference Base Array - 6143.2520, Guide Post, Low Profile Quattro Spike, Long - 6143.2521, Impaction Cap - 6143.2522, Removal Tool - 6143.2523, Guide Post, Low Profile Quattro Spike, Short - 6143.2524, Verification Probe - 6143.2525, Clamp Driver - 6143.2526, Low Profile Quattro Spike, Medium - 6143.2527, Impaction Cap, Low Profile Quattro Spike - 6143.2528, Guide Post, Low Profile Quattro Spike, Medium - 6143.2529, Awl Array, 15mm - 6143.2531, Drill Array, 15mm - 6143.2532, Pedicle Probe Array, 15mm - 6143.2533, Tap Array, 15mm - 6143.2534, Driver Array, 15mm - 6143.2535, Driver Array, CREO MIS, 15mm - 6143.2536, Awl Array, 17mm - 6143.2537, Tap Array, 17mm - 6143.2538, Driver Array, No Sleeve - 6143.2539, Drill Array, 17mm - 6143.2540, High Speed Drill Array - 6143.2541, Passive Tube Array, 15mm, GPS - 6143.2542, Scalpel Handle, 15mm, GPS - 6143.2543, Scalpel Handle, 17mm, GPS - 6143.2544, Intra-Op CT Registration Fixture - 6143.2545, Intra-Op CT Registration Fixture Pivoting Arm - 6143.2546, High Speed Drill Guard - 6143.2550, High Speed Drill Array Sleeve, 15mm - 6143.2551, High Speed Drill Array Sleeve, 17mm - 6143.2552, Surveillance Marker, Percutaneous Pin, Long - 6143.2553, Surveillance Marker, Percutaneous Pin, Short - 6143.2554, Navigated High Speed Drill Guard, AQRate - 6143.2555, Surveillance Marker, Percutaneous Pin, Medium - 6143.2556, 4.5/4.75 Rod Attachment, Short - 6143.2560, 4.5/4.75 Rod Attachment, Long - 6143.2561, 5.5 Rod Attachment, Short - 6143.2562, 5.5 Rod Attachment, Long - 6143.2563, 6.35 Rod Attachment, Short - 6143.2564, 6.35 Rod Attachment, Long - 6143.2565, 2.5mm Pilot Drill, GPS - 6143.2570, 2.5mm Reaming Pilot Drill, GPS - 6143.2571, 3.5mm Reaming Pilot Drill, GPS - 6143.2572, 4.0mm Reaming Pilot Drill, GPS - 6143.2573, 5.0mm Reaming Pilot Drill, GPS - 6143.2574, 6.0mm Reaming Pilot Drill, GPS - 6143.2575, High Speed Drill Tip 2.5mm - 6143.2580, High Speed Drill Tip 3.0mm - 6143.2581, High Speed Drill Tip 3.5mm - 6143.2582, High Speed Drill Tip 4.0mm - 6143.2583, High Speed Drill Tip 4.5mm - 6143.2584, High Speed Drill Tip 5.0mm - 6143.2585, High Speed Drill Tip 5.5mm - 6143.2586, High Speed Drill Tip 6.0mm - 6143.2587, Ball Tip Bit, AQRate, 2.5mm - 6143.2589, Pedicle Awl, GPS - 6143.2601, Pedicle Probe, Straight, GPS - 6143.2602, Thoracic Pedicle Probe, GPS - 6143.2604, Decorticating Awl, GPS - 6143.2605, 6.0mm Tap, GPS - 6143.2614, 7.0mm Tap, GPS - 6143.2615, 2.0mm Tap, GPS - 6143.2616, 2.5mm Tap, GPS - 6143.2617, 3.0mm Tap, GPS - 6143.2618, 3.5mm Tap, GPS - 6143.2619, 4.0mm Tap, GPS - 6143.2620, 4.5mm Tap, GPS - 6143.2621, 5.0mm Tap, GPS - 6143.2622, 5.5mm Tap, GPS - 6143.2623, 6.5mm Tap, GPS - 6143.2624, 7.5mm Tap, GPS - 6143.2625, 8.5mm Tap, GPS - 6143.2626, 9.5mm Tap, GPS - 6143.2627, 10.5mm Tap, GPS - 6143.2628, 8.0mm Tap, GPS - 6143.2629, REVERE 4.5 Rigid Monoaxial Screwdriver, GPS - 6143.2630, REVERE 4.5 Rigid Screwdriver, GPS - 6143.2631, REVERE 5.5 Rigid Monoaxial Screwdriver, GPS - 6143.2632, REVERE 5.5 Rigid Screwdriver, Threaded, GPS - 6143.2634, REVERE 5.5 Rigid Screwdriver, GPS - 6143.2635, REVERE 6.35 Rigid Monoaxial Screwdriver, GPS - 6143.2636, REVERE 6.35 Rigid Screwdriver, GPS - 6143.2637, CREO 5.5 Rigid Screwdriver, GPS - 6143.2651, CREO 4.75 Reduction Screwdriver, Threaded, GPS - 6143.2652, CREO 5.5 Reduction Screwdriver, Threaded, GPS - 6143.2653, CREO 4.75 Rigid Screwdriver, Threaded, GPS - 6143.2654, CREO 5.5 Rigid Screwdriver, Threaded, GPS - 6143.2655, CREO 4.75 Monoaxial Rigid Screwdriver, Threaded, GPS - 6143.2656, CREO 5.5 Monoaxial Rigid Screwdriver, GPS - 6143.2657, CREO 5.5 Monoaxial Rigid Screwdriver, Threaded, GPS - 6143.2658, CREO AMP Cannulated Modular Screwdriver, GPS - 6143.2659, CREO AMP Modular Screwdriver, GPS - 6143.2660, CREO MIS Cannulated Screwdriver, 30mm, GPS - 6143.2680, CREO MIS Cannulated Screwdriver, 10mm, GPS - 6143.2681, Cannula A, 9mm x 375mm - 6143.2682, Cannula B, 15mm x 355mm - 6143.2684, Cannula, 15mm End Effector, 80mm - 6143.2686, Cannula, 15mm End Effector, 120mm - 6143.2687, Cannula Pusher, 15mm - 6143.2690, CREO MIS Screwdriver, 30mm, GPS - 6143.2694, CREO MIS Screwdriver, 10mm, GPS - 6143.2695, CREO 6.35 Rigid Driver, Threaded, GPS - 6143.2696, CREO 6.35 Reduction Driver, Threaded, GPS - 6143.2697, MIS Awl, GPS - 6143.2701, MIS Awl, Cannulated for 1.6mm k-wire, GPS - 6143.2702, 4.5mm Cannulated Tap, GPS - 6143.2721, 5.0mm Cannulated Tap, GPS - 6143.2722, 5.5mm Cannulated Tap, GPS - 6143.2723, 6.5mm Cannulated Tap, GPS - 6143.2724, 7.5mm Cannulated Tap, GPS - 6143.2725, 8.5mm Cannulated Tap, GPS - 6143.2726, REVOLVE Cannulated Screwdriver, GPS - 6143.2731, REVOLVE Reduction Sleeve, GPS - 6143.2732, REVOLVE Screwdriver, GPS - 6143.2733, Cannula B, 17mm x 355mm - 6143.2744, End Effector Sleeve, 17mm - 6143.2745, Cannula, 17mm End Effector, 70mm, GPS - 6143.2746, Cannula, 17mm End Effector, 100mm, GPS - 6143.2747, Cannula Pusher, 17mm - 6143.2749, 5.0/4.0mm Drill, GPS - 6143.2751, 6.0/5.0mm Drill, GPS - 6143.2752, 6.5/5.5mm Drill, GPS - 6143.2753, 7.5/6.5mm Drill, GPS - 6143.2754, 5.0/4.0mm Cortical Tap, Dual Outer Diameter, 20mm, GPS - 6143.2770, 5.0/4.0mm Cortical Tap, Dual Outer Diameter, 35mm, GPS - 6143.2771, 5.5/4.5mm Cortical Tap, Dual Outer Diameter, 20mm, GPS - 6143.2772, 5.5/4.5mm Cortical Tap, Dual Outer Diameter, 35mm, GPS - 6143.2773, 6.0/5.0mm Cortical Tap, Dual Outer Diameter, 20mm, GPS - 6143.2774, 6.0/5.0mm Cortical Tap, Dual Outer Diameter, 35mm, GPS - 6143.2775, 6.5/5.5mm Cortical Tap, Dual Outer Diameter, 20mm, GPS - 6143.2776, 6.5/5.5mm Cortical Tap, Dual Outer Diameter, 35mm, GPS - 6143.2777, 7.5/6.5mm Cortical Tap, Dual Outer Diameter, 20mm, GPS - 6143.2778, 7.5/6.5mm Cortical Tap, Dual Outer Diameter, 35mm, GPS - 6143.2779, Cannula A, 9mm x 250mm, Aluminum - 6143.2782, Cannula A, 9mm x 270mm, Aluminum - 6143.2783, Cannula B, 15mm x 230mm, Aluminum - 6143.2784, Cannula B, 15mm x 270mm, Aluminum - 6143.2785, Cannula B, 17mm x 230mm, Aluminum - 6143.2786, MIS Awl, Cannulated for 2.4mm k-wire, GPS - 6143.2802, SI-LOK Cannulated Drill, 6.5mm, GPS - 6143.2810, SI-LOK Cannulated Drill, 7.5mm, GPS - 6143.2811, SI-LOK Cannulated Drill, 8.5mm, GPS - 6143.2812, SI-LOK Cannulated Drill, 9.5mm, GPS - 6143.2813, SI-LOK Cannulated Drill, 10.5mm, GPS - 6143.2814, SI-LOK Cannulated Tap, 8.0mm, GPS - 6143.2820, SI-LOK Cannulated Tap, 10.0mm, GPS - 6143.2821, SI-LOK Cannulated Screwdriver, GPS - 6143.2830, GPS Ball tip Probe - 6143.2840, Cannula A, 9mm x 405mm - 6143.2843, Cannula A, 9mm x 250mm - 6143.2844, Cannula B, 15mm x 385mm - 6143.2845, End Effector Sleeve, 15mm - 6143.2846, Cannula, 15mm End Effector, 150mm, GPS - 6143.2848, SI-LOK Drill, 6.5mm , GPS - 6143.2850, SI-LOK Drill, 7.5mm, GPS - 6143.2851, SI-LOK Drill, 8.5mm , GPS - 6143.2852, SI-LOK Drill, 9.5mm , GPS - 6143.2853, SI-LOK Drill, 10.5mm , GPS - 6143.2854, SI-LOK Tap, 8.0mm, GPS - 6143.2855, SI-LOK Tap, 10.0mm, GPS - 6143.2856, SI-LOK Screwdriver, GPS - 6143.2857, T15 Driver, GPS - 6143.2860, T4 Driver, GPS - 6143.2861, T5 Driver, GPS - 6143.2862, T6 Driver, GPS - 6143.2863, T7 Driver, GPS - 6143.2864, T8 Driver, GPS - 6143.2865, T9 Driver, GPS - 6143.2866, T10 Driver, GPS - 6143.2867, T20 Driver, GPS - 6143.2868, T25 Drive

תאריך אישור:

2020-01-09