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) |
|---|---|---|---|
| Apr 3, 2026 | XTANT Medical Holdings, Inc XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, Part Number X073-6555-DL. Open, Classified |
MNI | K152132 |
| Aug 24, 2023 | Medicrea International PASS LP, REF numbers:
a) B02315535Z,
b) B02315540Z,
c) B02315545Z,
d) B02315550Z,
e) B02316535Z,
f) B02316540Z,
g) B02316545Z,
h) B02316550Z,
i) B02317540Z,
j) B02317545Z,
k) B02317550Z; i Open, Classified |
MNI | K110497 |
| Mar 20, 2019 | CTL Medical Corporation CTL Medical Hex Driver, 1/4" Square QC, 4.0 Ratcheting Ref 015.7050 Terminated |
MNI | K132365 |
| Jun 21, 2017 | Valorem Surgical LLC PALLAS M/MAXIMIS Rod Pusher B. 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 Guide Wire. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015.
Intended for poste Terminated |
MNI | K140359 |
| Jun 21, 2017 | Valorem Surgical LLC PALLAS M/MAXIMIS Set Screw Starter. 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 Persuader. 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 Driver Shaft (5Hex, Set Screw) 1/4 inch Drive. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation Syste Terminated |
MNI | K140359 |
| Jun 21, 2017 | Valorem Surgical LLC PALLAS M/MAXIMIS Body Alignment Driver. 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 C. Probe. 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 S. Probe. 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 Nut Inserter B. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015.
Intended for p Terminated |
MNI | K140359 |
| Jun 21, 2017 | Valorem Surgical LLC PALLAS M/MAXIMIS Head Holder. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015.
Intended for post Terminated |
MNI | K140359 |
| Jun 21, 2017 | Valorem Surgical LLC PALLAS M/MAXIMIS MISS/MIS Tapper 7.5 mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015.
Intend Terminated |
MNI | K140359 |
| Jun 21, 2017 | Valorem Surgical LLC PALLAS M/MAXIMIS MIS Anti Torque. 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 I Handle. 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 Ratchet T Handle. 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 Torque Handle. 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 Rod Pusher Angled. 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 Rod Checker and T-Bar. 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 MIS Alignment Driver. 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 MISS/MIS Compressor and Rod Tightener. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System throug Terminated |
MNI | K140359 |
| Jun 21, 2017 | Valorem Surgical LLC PALLAS M/MAXIMIS Rod Gauge. 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 Rod Checker. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015.
Intended for post Terminated |
MNI | K140359 |
| Jun 21, 2017 | Valorem Surgical LLC PALLAS M/MAXIMIS Rod Bender. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015.
Intended for poste Terminated |
MNI | K140359 |
| Jun 21, 2017 | Valorem Surgical LLC PALLAS M/MAXIMIS Nut Driver 4.5 Star and Final Driver 4.0. 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 Anti Torque Device. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015.
Intended f Terminated |
MNI | K140359 |
| Jun 21, 2017 | Valorem Surgical LLC PALLAS M/MAXIMIS MISS/MIS Poly Screw Driver. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015.
In Terminated |
MNI | K140359 |
| Jun 21, 2017 | Valorem Surgical LLC PALLAS M/MAXIMIS Compass. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015.
Intended for posterio Terminated |
MNI | K140359 |
| Jun 21, 2017 | Valorem Surgical LLC PALLAS M/MAXIMIS Extension Sleeve. 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 Extension Guide Bush. 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 Extension Driver. 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 Extension Block. 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 Closed Extension. 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 Open Extension (Large). Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015.
Intend Terminated |
MNI | K140359 |
| Jun 21, 2017 | Valorem Surgical LLC PALLAS M/MAXIMIS Open Extension (Small). Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015.
Intend Terminated |
MNI | K140359 |
| Jun 21, 2017 | Valorem Surgical LLC PALLAS M/MAXIMIS MIS Tapper 6.5mm. 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 MIS Tapper 5.5mm. 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 MIS Pedicle Cut. 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 Dilator B. 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 Dilator A. 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 Dilator Handle. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015.
Intended for p Terminated |
MNI | K140359 |
| Jun 21, 2017 | Valorem Surgical LLC PALLAS M/MAXIMIS Cross Link Torque Handle. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015.
Inte Terminated |
MNI | K140359 |
| Jun 21, 2017 | Valorem Surgical LLC PALLAS M/MAXIMIS Reduction B. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015.
Intended for post Terminated |
MNI | K140359 |
| Jun 21, 2017 | Valorem Surgical LLC PALLAS M/MAXIMIS Reduction A. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015.
Intended for post Terminated |
MNI | K140359 |
| Jun 21, 2017 | Valorem Surgical LLC PALLAS M/MAXIMIS Inside Bender (L) and (R). Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015.
Int Terminated |
MNI | K140359 |
| Jun 21, 2017 | Valorem Surgical LLC PALLAS M/MAXIMIS Marking Pin (Round Jaw). 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 Marking Pin (Smooth). 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 Distractor. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015.
Intended for poste Terminated |
MNI | K140359 |
| Jun 21, 2017 | Valorem Surgical LLC PALLAS M/MAXIMIS Compressor. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015.
Intended for poste Terminated |
MNI | K140359 |
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