Panels › Orthopedic › Product code MNH · Class 2
Orthosis, Spondylolisthesis Spinal Fixation
Regulation 888.3070
0510(k)s in 12 months (309 all time)
0recalls in 12 months (15 all time)
14recalls that name a 510(k)
Top companies in MNH
| Company | 510(k)s | Recalls |
|---|---|---|
| Medtronic Sofamor Danek | 18 | 0 |
| Acromed Corp. | 14 | 0 |
| Depuyacromed | 13 | 0 |
| Sofamor Danek | 10 | 0 |
| Ebi, L.P. | 6 | 3 |
| Howmedica Osteonics | 9 | 0 |
| Advanced Spine Fixation Systems, Inc. | 8 | 0 |
| Stryker Spine | 4 | 3 |
| Ortho Tec, LLC | 6 | 0 |
| Solco Biomedical Co., Ltd. | 6 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 27, 2017 | XTANT MEDICAL INC 5.5mm Diameter x 500mm CoCr Straight Rod, Model number X077-0420. The product is packaged in plastic bags with one piece per bag.
Product Usage:
The 5.5mm dia. X 500 mm CoCr Straight Rod is an acces Terminated |
MNH | K120832 |
| Nov 22, 2016 | Amendia, Inc Savannah-T Straight Rod, 200mm, Part Number 10704-200; Savannah-T Straight Rod, 250mm, Part Number 10704-250; Savannah T-Straight Rod 300mm, Part Number 10704-300; Savannah-T Straight Rod, 400mm, Part Terminated |
MNH | K132925 K152920 +2 |
| Jul 10, 2015 | Exactech, Inc. Altiva / Exactech Spine, Large Set Screw, Catalog Number 28202, Lot Number AS05107.
Intended to provide immobilization and stabilization of spinal segments. Terminated |
MNH | K051216 |
| Jun 22, 2015 | X Spine Systems Inc Fortex" Pedicle Screw System Continuous Radius Rod 5.5 - 50mm, X-Spine Systems, Inc., 452 Alexandersville Road Miamisburg, OH 45342 Phone: 937-847-8400 Terminated |
MNH | K120832 |
| Apr 22, 2015 | X Spine Systems Inc Xpress System Pedicle Screw Assembly, 5.5 x 55mm. An internal fixation device for spinal surgery consisting of rods, pedicle screw assemblies (screw, cap, yoke) and cross bar connector assemblies. Terminated |
MNH | K120832 |
| Mar 11, 2013 | Synthes USA HQ, Inc. Synthes Spine 5.2mm Titanium Click ' X Pedicle Screw Dual Core 40 mm Thread Length, Part Number 487.072.
Intended to provide precise and segmental stabilization of the spine in skeletally mature pati Terminated |
MNH | K992739 |
| Oct 29, 2012 | Alphatec Spine, Inc. ILLlCO MIS Posterior Fixation System, Bone-screw Internal Spinal Fixation System,
Orthosis, Spinal Pedical Fixation
Orthosis, Spondylolisthesis Spinal Fixation
The ILLICO MIS Posterior Fixation Sys Terminated |
MNH | K042673 K071890 |
| Sep 22, 2009 | EBI, L.P. Fixed Closed Screw (Ti);
5.0MM (D) x 25MM (L);
Made in USA, Biomet Spine, Parsippany, NJ 07054
The screw devices are an internal fixation device intended to aid in the alignment and stabilization of Terminated |
MNH | K993956 |
| Sep 22, 2009 | EBI, L.P. Fixed Open Screw (TI);
7.0MM (D) x 30MM (L);
Made In USA, Biomet Spine, Parsippany, NJ 07054
The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fr Terminated |
MNH | K993956 |
| Sep 22, 2009 | EBI, L.P. Fixed Closed Screw, 6.5mm (D) x 40mm (L),
Made in USA; Biomet Spine, Parsippany, NJ
The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures t Terminated |
MNH | K993956 |
| Sep 16, 2009 | Stryker Spine Stryker Trio Connector Hex Socket for Torque Wrench 3.5MM
Not Sterile:
Manufactured by: Stryker Spine SAS, Cestas, France;
Distributed in the USA by: Stryker Spine, Allendale, NJ 07401
The Trio 3.5MM Terminated |
MNH | K032855 K052971 +1 |
| Aug 19, 2009 | X Spine Systems Inc Capless Li Pedicle Screw System, Diameters - 4.75mm, 5.5mm, 6.5mm, 7.5mm, 8.25mm, Lengths 30mm-55mm, labeled non-sterile.
The Capless LI Pedicle Screw System is indicated for the treatment of sever s Terminated |
MNH | K072282 |
| Jul 7, 2009 | Stryker Spine Stryker Mantis Rod Inserter Inner Shaft; Non Sterile; Manufactured by Stryker Spine SAS, Cestas France. Distributed by Stryker Spine, Allendale, NJ 07401-1677.
The MANTIS Spinal System is intended f Terminated |
MNH | K061813 |
| Jul 7, 2009 | Stryker Spine Stryker Mantis Rod Inserter; Non Sterile, Manufactured by Stryker Spine SAS, Cestas, France. Distributed by Howmedica Osteonics Corp; 325 Corporate Drive, Mahwah, NJ 07430.
The MANTIS Spinal System Terminated |
MNH | K061813 |
| Sep 21, 2005 | Stryker Howmedica Osteonics Corp. The TRIO Spondylolisthesis Reduction Instrument is a Class I Manual Surgical Instrument unique to the implantation of Stryker Spine TRIO PS this instrument is intended for use in the reduction of dege Terminated |
MNH | None listed |
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