Valorem Surgical LLC

FDA Regulatory Profile

Summary

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

Recent Recalls

NumberClassProductDate
Z-2972-2017Class IIPALLAS M/MAXIMIS Marking Pin (Smooth). Part of MAXIMIS Pedicle Screw Spinal Fixation System. ValoreJune 21, 2017
Z-3014-2017Class IIPALLAS M/MAXIMIS Set Screw Starter. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem SJune 21, 2017
Z-2925-2017Class IIPALLAS M/MAXIMIS MIS Screw5.5 x 55mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. ValoremJune 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-2971-2017Class IIPALLAS M/MAXIMIS Distractor. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem SurgicalJune 21, 2017
Z-3004-2017Class IIPALLAS M/MAXIMIS I Handle. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, June 21, 2017
Z-3010-2017Class IIPALLAS M/MAXIMIS C. Probe. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, June 21, 2017
Z-2916-2017Class IIPALLAS M/MAXIMIS MIS Screw 6.5 x 50mm and 6.5 x 5.0 mm screw. Part of MAXIMIS Pedicle Screw Spinal FJune 21, 2017
Z-2875-2017Class IIPALLAS M/MAXIMIS 60mm Curved Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem SurJune 21, 2017
Z-3015-2017Class IIPALLAS M/MAXIMIS Guide Wire. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem SurgicalJune 21, 2017
Z-2946-2017Class IIPALLAS M/MAXIMIS 80mm Curved Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem SurJune 21, 2017
Z-2970-2017Class IIPALLAS M/MAXIMIS Compressor. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem SurgicalJune 21, 2017
Z-2906-2017Class IIPALLAS M/MAXIMIS Poly Screw 7.5 x 50mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. ValorJune 21, 2017
Z-2931-2017Class IIPALLAS M/MAXIMIS Poly Screw 5.5 x 35mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. ValorJune 21, 2017
Z-2965-2017Class IIPALLAS M/MAXIMIS Poly Screw Driver. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem SJune 21, 2017
Z-3012-2017Class IIPALLAS M/MAXIMIS Driver Shaft (5Hex, Set Screw) 1/4 inch Drive. Part of MAXIMIS Pedicle Screw SpinalJune 21, 2017
Z-2980-2017Class IIPALLAS M/MAXIMIS Dilator B. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical,June 21, 2017
Z-2937-2017Class IIPALLAS M/MAXIMIS Poly Screw 6.5 x 45mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. ValoJune 21, 2017
Z-2961-2017Class IIPALLAS M/MAXIMIS Awl. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, ChicaJune 21, 2017
Z-2985-2017Class IIPALLAS M/MAXIMIS Open Extension (Large). Part of MAXIMIS Pedicle Screw Spinal Fixation System. ValoJune 21, 2017

Recent 510(k) Clearances

K-NumberDeviceDate
K140359MAXIMIS SPINAL FIXATION SYSTEMJanuary 7, 2015