Panels › Orthopedic › Product code MNI · Class 2
Orthosis, Spinal Pedicle Fixation
Regulation 888.3070
0510(k)s in 12 months (303 all time)
1recalls in 12 months (213 all time)
212recalls that name a 510(k)
Top companies in MNI
| Company | 510(k)s | Recalls |
|---|---|---|
| Valorem Surgical LLC | 0 | 144 |
| Allez Spine, LLC | 1 | 27 |
| Medtronic Sofamor Danek | 25 | 0 |
| K2m, Inc. | 15 | 0 |
| Spine Wave, Inc. | 11 | 0 |
| Blackstone Medical, Inc. | 7 | 3 |
| Stryker Spine | 7 | 2 |
| Spinal USA | 8 | 0 |
| Spinal Solutions, LLC | 0 | 8 |
| Life Spine | 7 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 21, 2017 | Valorem Surgical LLC PALLAS M/MAXIMIS MIS Screw 7.5 x 40mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015.
Intended Terminated |
MNI | K140359 |
| Jun 21, 2017 | Valorem Surgical LLC PALLAS M/MAXIMIS MIS Screw 7.5 x 35mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015.
Intended Terminated |
MNI | K140359 |
| Jun 21, 2017 | Valorem Surgical LLC PALLAS M/MAXIMIS MIS Screw 6.5 x 55mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015.
Intended Terminated |
MNI | K140359 |
| Jun 21, 2017 | Valorem Surgical LLC PALLAS M/MAXIMIS MIS Screw 6.5 x 50mm and 6.5 x 5.0 mm screw. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System Terminated |
MNI | K140359 |
| Jun 21, 2017 | Valorem Surgical LLC PALLAS M/MAXIMIS MIS Screw 6.5 x 45mm and 6.5 x 4.5 screw. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System thr Terminated |
MNI | K140359 |
| Jun 21, 2017 | Valorem Surgical LLC PALLAS M/MAXIMIS MIS Screw 6.5 x 40mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015.
Intended Terminated |
MNI | K140359 |
| Jun 21, 2017 | Valorem Surgical LLC PALLAS M/MAXIMIS MIS Screw 6.5 x 35mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015.
Intended Terminated |
MNI | K140359 |
| Jun 21, 2017 | Valorem Surgical LLC PALLAS M/MAXIMIS Poly Screw 5.5 x 50mm and 5.5 x 5.0 mm screw. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System Terminated |
MNI | K140359 |
| Jun 21, 2017 | Valorem Surgical LLC PALLAS M/MAXIMIS Polyaxial and MIS Screw, 5.5 x 45mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through Terminated |
MNI | K140359 |
| Jun 21, 2017 | Valorem Surgical LLC PALLAS M/MAXIMIS Polyaxial Screw and MIS Screw, 5.5 x 40mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System th Terminated |
MNI | K140359 |
| Jun 21, 2017 | Valorem Surgical LLC PALLAS M/MAXIMIS Poly Screw 5.5 x 35mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015.
Intende Terminated |
MNI | K140359 |
| Jun 21, 2017 | Valorem Surgical LLC PALLAS M/MAXIMIS Poly Screw 5.5 x 30mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015.
Intende Terminated |
MNI | K140359 |
| Jun 21, 2017 | Valorem Surgical LLC PALLAS M/MAXIMIS Poly Screw 7.5 x 55mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015.
Intende Terminated |
MNI | K140359 |
| Jun 21, 2017 | Valorem Surgical LLC PALLAS M/MAXIMIS Poly Screw 7.5 x 50mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015.
Intende Terminated |
MNI | K140359 |
| Jun 21, 2017 | Valorem Surgical LLC PALLAS M/MAXIMIS Poly Screw 7.5 x 45mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015.
Intende Terminated |
MNI | K140359 |
| Jun 21, 2017 | Valorem Surgical LLC PALLAS M/MAXIMIS Poly Screw 7.5 x 40mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015.
Intende Terminated |
MNI | K140359 |
| Jun 21, 2017 | Valorem Surgical LLC PALLAS M/MAXIMIS Poly Screw 6.5 x 55mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015.
Intende Terminated |
MNI | K140359 |
| Jun 21, 2017 | Valorem Surgical LLC PALLAS M/MAXIMIS Poly Screw 6.5 x 50mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015.
Intende Terminated |
MNI | K140359 |
| Jun 21, 2017 | Valorem Surgical LLC PALLAS M/MAXIMIS Poly Screw 6.5 x 45mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015.
Intende Terminated |
MNI | K140359 |
| Jun 21, 2017 | Valorem Surgical LLC PALLAS M/MAXIMIS Poly Screw 6.5 x 40mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015.
Intende Terminated |
MNI | K140359 |
| Jun 21, 2017 | Valorem Surgical LLC PALLAS M/MAXIMIS Poly Screw 5.5 x 50mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015.
Intende Terminated |
MNI | K140359 |
| Jun 21, 2017 | Valorem Surgical LLC PALLAS M/MAXIMIS Poly Screw 5.5 x 30mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015.
Intende Terminated |
MNI | K140359 |
| Jun 21, 2017 | Valorem Surgical LLC PALLAS M/MAXIMIS Set Screw. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015.
Intended for poster Terminated |
MNI | K140359 |
| Jun 21, 2017 | Valorem Surgical LLC PALLAS M/MAXIMIS 120mm MIS Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015.
Intended for po Terminated |
MNI | K140359 |
| Jun 21, 2017 | Valorem Surgical LLC PALLAS M/MAXIMIS 60mm MIS Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015.
Intended for pos Terminated |
MNI | K140359 |
| Jun 21, 2017 | Valorem Surgical LLC PALLAS M/MAXIMIS 55mm MIS Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015.
Intended for pos Terminated |
MNI | K140359 |
| Jun 21, 2017 | Valorem Surgical LLC PALLAS M/MAXIMIS 50mm MIS Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015.
Intended for pos Terminated |
MNI | K140359 |
| Jun 21, 2017 | Valorem Surgical LLC PALLAS M/MAXIMIS 45mm MIS Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015.
Intended for pos Terminated |
MNI | K140359 |
| Jun 21, 2017 | Valorem Surgical LLC PALLAS M/MAXIMIS 35mm MIS Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015.
Intended for pos Terminated |
MNI | K140359 |
| Jun 21, 2017 | Valorem Surgical LLC PALLAS M/MAXIMIS 40mm MIS Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015.
Intended for pos Terminated |
MNI | K140359 |
| Jun 21, 2017 | Valorem Surgical LLC PALLAS M/MAXIMIS 80mm MIS Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015.
Intended for pos Terminated |
MNI | K140359 |
| Jun 21, 2017 | Valorem Surgical LLC PALLAS M/MAXIMIS 70mm MIS Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015.
Intended for pos Terminated |
MNI | K140359 |
| Jun 21, 2017 | Valorem Surgical LLC PALLAS M/MAXIMIS 60mm MIS Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015.
Intended for pos Terminated |
MNI | K140359 |
| Jun 21, 2017 | Valorem Surgical LLC PALLAS M/MAXIMIS 50mm MIS Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015.
Intended for pos Terminated |
MNI | K140359 |
| Jun 21, 2017 | Valorem Surgical LLC PALLAS M/MAXIMIS 45mm MIS . Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015.
Intended for poster Terminated |
MNI | K140359 |
| Jun 21, 2017 | Valorem Surgical LLC PALLAS M/MAXIMIS 40mm MIS rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015.
Intended for pos Terminated |
MNI | K140359 |
| Jun 21, 2017 | Valorem Surgical LLC PALLAS M/MAXIMIS 35mm MIS rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015.
Intended for pos Terminated |
MNI | K140359 |
| Jun 21, 2017 | Valorem Surgical LLC PALLAS M/MAXIMIS 30mm Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015.
Intended for posteri Terminated |
MNI | K140359 |
| Jun 21, 2017 | Valorem Surgical LLC PALLAS M/MAXIMIS MIS Poly Screw Driver B. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015.
Inten Terminated |
MNI | K140359 |
| Jun 21, 2017 | Valorem Surgical LLC PALLAS M/MAXIMIS 5.5 x 35mm Curved Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015.
Intende Terminated |
MNI | K140359 |
| Jun 21, 2017 | Valorem Surgical LLC PALLAS M/MAXIMIS 5.5 x 05mm Curved Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015.
Intende Terminated |
MNI | K140359 |
| Jun 21, 2017 | Valorem Surgical LLC PALLAS M/MAXIMIS Large Crosslink. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015.
Intended for Terminated |
MNI | K140359 |
| Jun 21, 2017 | Valorem Surgical LLC PALLAS M/MAXIMIS Small Crosslink. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015.
Intended for Terminated |
MNI | K140359 |
| Jun 21, 2017 | Valorem Surgical LLC PALLAS M/MAXIMIS Crosslink 50-70mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015.
Intended fo Terminated |
MNI | K140359 |
| Jun 21, 2017 | Valorem Surgical LLC PALLAS M/MAXIMIS 60mm Curved Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015.
Intended for Terminated |
MNI | K140359 |
| Jun 21, 2017 | Valorem Surgical LLC PALLAS M/MAXIMIS 50mm Curved Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015.
Intended for Terminated |
MNI | K140359 |
| Jun 21, 2017 | Valorem Surgical LLC PALLAS M/MAXIMIS 5.5 mm Instrument Tap. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015.
Intende Terminated |
MNI | K140359 |
| Feb 13, 2017 | New Era Orthopaedics, LLc Modera Modular Pedicle Screw System Shank Insertion Instrument, 3-107-07 Terminated |
MNI | K141253 K150647 |
| Oct 17, 2015 | Synthes (USA) Products LLC 5.0mm Unit Rod 270mm, 5.0mm Unit Rod 290mm, 5.0mm Unit Rod 310mm,
5.0mm Unit Rod 330mm, 5.0mm Unit Rod 350mm, 5.0mm Unit Rod 370mm,
5.0mm Unit Rod 390mm, 5.0mm Unit Rod 410mm, 5.0mm Unit Rod 430mm, Terminated |
MNI | K020517 |
| Mar 18, 2014 | Exactech, Inc. Gibralt Spine System Polyaxial Screw
Intended to promote fusion of the cervical spine, and the thoracic spine, (C3-T3), the Gibralt Spinal System is indicated for the following: DDD (neck pain of dis Terminated |
MNI | K110197 |
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