Valorem Surgical LLC

FDA Regulatory Profile

Summary

Total Recalls
144
510(k) Clearances
1
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2944-2017Class IIPALLAS M/MAXIMIS 60mm Curved and Precontoured Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation SysJune 21, 2017
Z-2978-2017Class IIPALLAS M/MAXIMIS Dilator Handle. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem SurgJune 21, 2017
Z-2914-2017Class IIPALLAS M/MAXIMIS MIS Screw 6.5 x 40mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. ValoreJune 21, 2017
Z-2949-2017Class IIPALLAS M/MAXIMIS 45mm Straight Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem SJune 21, 2017
Z-2983-2017Class IIPALLAS M/MAXIMIS MIS Tapper 6.5mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem SuJune 21, 2017
Z-3013-2017Class IIPALLAS M/MAXIMIS Persuader. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical,June 21, 2017
Z-2982-2017Class IIPALLAS M/MAXIMIS MIS Tapper 5.5mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem SuJune 21, 2017
Z-2905-2017Class IIPALLAS M/MAXIMIS Poly Screw 7.5 x 45mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. ValorJune 21, 2017
Z-2876-2017Class IIPALLAS M/MAXIMIS Crosslink 50-70mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem SJune 21, 2017
Z-2883-2017Class IIPALLAS M/MAXIMIS 35mm MIS rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem SurgicJune 21, 2017
Z-3007-2017Class IIPALLAS M/MAXIMIS Head Holder. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem SurgicaJune 21, 2017
Z-2912-2017Class IIPALLAS M/MAXIMIS Poly Screw 5.5 x 50mm and 5.5 x 5.0 mm screw. Part of MAXIMIS Pedicle Screw Spinal June 21, 2017
Z-2880-2017Class IIPALLAS M/MAXIMIS 5.5 x 35mm Curved Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. ValorJune 21, 2017
Z-3015-2017Class IIPALLAS M/MAXIMIS Guide Wire. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem SurgicalJune 21, 2017
Z-2901-2017Class IIPALLAS M/MAXIMIS Poly Screw 6.5 x 45mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. ValorJune 21, 2017
Z-3016-2017Class IIPALLAS M/MAXIMIS Rod Pusher B. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem SurgicJune 21, 2017
Z-2995-2017Class IIPALLAS M/MAXIMIS Rod Bender. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem SurgicalJune 21, 2017
Z-2933-2017Class IIPALLAS M/MAXIMIS Poly Screw 5.5 x 55mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. ValoJune 21, 2017
Z-2891-2017Class IIPALLAS M/MAXIMIS 35mm MIS Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem SurgicJune 21, 2017
Z-3005-2017Class IIPALLAS M/MAXIMIS MIS Anti Torque. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem SurJune 21, 2017

Recent 510(k) Clearances

K-NumberDeviceDate
K140359MAXIMIS SPINAL FIXATION SYSTEMJanuary 7, 2015