Valorem Surgical LLC

FDA Regulatory Profile

Summary

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

Recent Recalls

NumberClassProductDate
Z-3006-2017Class IIPALLAS M/MAXIMIS MISS/MIS Tapper 7.5 mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. ValoJune 21, 2017
Z-2930-2017Class IIPALLAS M/MAXIMIS MIS Screw 6.5 x 55mm and 6.5 x 5.5 mm screw. Part of MAXIMIS Pedicle Screw Spinal FJune 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-2964-2017Class IIPALLAS M/MAXIMIS Wall Check. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem SurgicalJune 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-2962-2017Class IIPALLAS M/MAXIMIS Tapper 5.5. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem SurgicalJune 21, 2017
Z-2995-2017Class IIPALLAS M/MAXIMIS Rod Bender. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem SurgicalJune 21, 2017
Z-3005-2017Class IIPALLAS M/MAXIMIS MIS Anti Torque. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem SurJune 21, 2017
Z-3014-2017Class IIPALLAS M/MAXIMIS Set Screw Starter. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem SJune 21, 2017
Z-2926-2017Class IIPALLAS M/MAXIMIS MIS Screw 6.5 x 35mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. ValoreJune 21, 2017
Z-2891-2017Class IIPALLAS M/MAXIMIS 35mm MIS Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem SurgicJune 21, 2017
Z-2994-2017Class IIPALLAS M/MAXIMIS Nut Driver 4.5 Star and Final Driver 4.0. Part of MAXIMIS Pedicle Screw Spinal FixaJune 21, 2017
Z-2927-2017Class IIPALLAS M/MAXIMIS MIS Screw 6.5 x 40mm and 6.5 x 4.0 mm screw. Part of MAXIMIS Pedicle Screw Spinal FJune 21, 2017
Z-2917-2017Class IIPALLAS M/MAXIMIS MIS Screw 6.5 x 55mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. ValoreJune 21, 2017
Z-2989-2017Class IIPALLAS M/MAXIMIS Extension Guide Bush. Part of MAXIMIS Pedicle Screw Spinal Fixation System. ValoreJune 21, 2017
Z-2959-2017Class IIPALLAS M/MAXIMIS 400mm Straight Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem June 21, 2017
Z-3008-2017Class IIPALLAS M/MAXIMIS Nut Inserter B. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem SurgJune 21, 2017
Z-3016-2017Class IIPALLAS M/MAXIMIS Rod Pusher B. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem SurgicJune 21, 2017

Recent 510(k) Clearances

K-NumberDeviceDate
K140359MAXIMIS SPINAL FIXATION SYSTEMJanuary 7, 2015