Product code MRW ยท Class U
System, Facet Screw Spinal Device
7510(k)s in 12 months (79 all time)
0recalls in 12 months (4 all time)
3recalls that name a 510(k)
Top companies in MRW
| Company | 510(k)s | Recalls |
|---|---|---|
| Providence Medical Technology, Inc. | 9 | 0 |
| SurGenTec, LLC | 6 | 0 |
| Interventional Spine, Inc. | 2 | 2 |
| Medtronic Sofamor Danek, Inc. | 3 | 1 |
| Nuvasive, Inc. | 4 | 0 |
| Triage Medical, Inc. | 4 | 0 |
| Globus Medical, Inc. | 3 | 0 |
| Sc Medica | 3 | 0 |
| Alphatec Spine, Inc. | 2 | 0 |
| Amendia, Inc. | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 27, 2021 | Medtronic Sofamor Danek USA, Inc Braive Growth Modulation System Break-Off Set Screws - Product Usage: intended to limit further progression of the spinal curvature and provide correction of the thoracic curve while allowing continue Terminated |
MRW | None listed |
| Oct 4, 2011 | Osteomed, Lp OSTEOMED SPINE Facet Fixation System PrimaLOK FF Threaded Implant Driver Shaft OsteoMed L.P. 3885 Arapaho Road, Addison, Texas 75001 Terminated |
MRW | K102438 |
| Aug 18, 2011 | Interventional Spine Inc Catalog # 9024-00 or LSW-S-3040 for 4.5mm BONE-LOK PLS Implant
A sterile, canulated screw that is supplied as a stand-alone product. The 4.5mm BONE-LOK PLS Implant is also supplied as a component of Terminated |
MRW | K043351 |
| Aug 18, 2011 | Interventional Spine Inc PERPOS PLS, CATALOG #'s 9045-01 & 9045-02
A sterile, medical device kit consisting of the components listed in Table 1-1 below. The kit is used by medical professionals to stabilize the spine as an a Terminated |
MRW | K062391 |
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