Valorem Surgical LLC
FDA Regulatory Profile
Valorem Surgical LLC appears in FDA public data with 144 recalls, 1 510(k) clearance, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2927-2017, Class II) was initiated on June 21, 2017. Its most recent 510(k) clearance was granted on January 7, 2015.
Summary
- Total Recalls
- 144
- 510(k) Clearances
- 1
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2927-2017 | Class II | PALLAS M/MAXIMIS MIS Screw 6.5 x 40mm and 6.5 x 4.0 mm screw. Part of MAXIMIS Pedicle Screw Spinal F | June 21, 2017 |
| Z-2933-2017 | Class II | PALLAS M/MAXIMIS Poly Screw 5.5 x 55mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valo | June 21, 2017 |
| Z-2880-2017 | Class II | PALLAS M/MAXIMIS 5.5 x 35mm Curved Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valor | June 21, 2017 |
| Z-2901-2017 | Class II | PALLAS M/MAXIMIS Poly Screw 6.5 x 45mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valor | June 21, 2017 |
| Z-3016-2017 | Class II | PALLAS M/MAXIMIS Rod Pusher B. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgic | June 21, 2017 |
| Z-2962-2017 | Class II | PALLAS M/MAXIMIS Tapper 5.5. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical | June 21, 2017 |
| Z-3006-2017 | Class II | PALLAS M/MAXIMIS MISS/MIS Tapper 7.5 mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valo | June 21, 2017 |
| Z-2995-2017 | Class II | PALLAS M/MAXIMIS Rod Bender. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical | June 21, 2017 |
| Z-3005-2017 | Class II | PALLAS M/MAXIMIS MIS Anti Torque. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Sur | June 21, 2017 |
| Z-3014-2017 | Class II | PALLAS M/MAXIMIS Set Screw Starter. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem S | June 21, 2017 |
| Z-2926-2017 | Class II | PALLAS M/MAXIMIS MIS Screw 6.5 x 35mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valore | June 21, 2017 |
| Z-2891-2017 | Class II | PALLAS M/MAXIMIS 35mm MIS Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgic | June 21, 2017 |
| Z-2994-2017 | Class II | PALLAS M/MAXIMIS Nut Driver 4.5 Star and Final Driver 4.0. Part of MAXIMIS Pedicle Screw Spinal Fixa | June 21, 2017 |
| Z-2917-2017 | Class II | PALLAS M/MAXIMIS MIS Screw 6.5 x 55mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valore | June 21, 2017 |
| Z-2989-2017 | Class II | PALLAS M/MAXIMIS Extension Guide Bush. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valore | June 21, 2017 |
| Z-2959-2017 | Class II | PALLAS M/MAXIMIS 400mm Straight Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem | June 21, 2017 |
| Z-3008-2017 | Class II | PALLAS M/MAXIMIS Nut Inserter B. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surg | June 21, 2017 |
| Z-2956-2017 | Class II | PALLAS M/MAXIMIS 300mm Straight Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem | June 21, 2017 |
| Z-2936-2017 | Class II | PALLAS M/MAXIMIS Poly Screw 6.5 x 40mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valo | June 21, 2017 |
| Z-3015-2017 | Class II | PALLAS M/MAXIMIS Guide Wire. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical | June 21, 2017 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K140359 | MAXIMIS SPINAL FIXATION SYSTEM | January 7, 2015 |