Driver, Wire, And Bone Drill, Manual
Regulation 872.4120
2510(k)s in 12 months (33 all time)
0recalls in 12 months (11 all time)
9recalls that name a 510(k)
Top companies in DZJ
| Company | 510(k)s | Recalls |
|---|---|---|
| Stryker Instruments Div. of Stryker Corporation | 0 | 8 |
| 3D Systems | 3 | 0 |
| Medical Modeling, Inc. | 2 | 1 |
| Artech Corp. | 2 | 0 |
| KLS-Martin L.P. | 2 | 0 |
| Materialise NV | 2 | 0 |
| Medcad | 2 | 0 |
| Propel Orthodontics, LLC | 2 | 0 |
| Straumann Manufacturing Inc. | 0 | 2 |
| Techfit Digital Surgery | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 17, 2022 | Medical Modeling, Inc. 3D Systems VSP Reconstruction, Model: VSPR-301 Product: Scapula Marking Guide (Anatomically Shaped), Rx Only, Non-Sterile Open, Classified |
DZJ | K133907 |
| Oct 28, 2013 | Stryker Instruments Div. of Stryker Corporation REF 5100-088, TPS Micro Driver, For Use with Stryker Total Performance System
Caution Federal Law (USA) restricts the device to use by or on the order of a physician
Driver, Wire and Bone Drill; T Terminated |
DZJ | K943540 |
| Nov 16, 2011 | Stryker Instruments Div. of Stryker Corporation Left IBO Blade , for use with Stryker TPS or Core Reciprocating Saw, REF 5100-37-902S2, Stryker Instruments, Kalamazoo, MI.
Product Usage: The intended use of these devices is to cut bone and hard t Terminated |
DZJ | K040369 |
| Nov 16, 2011 | Stryker Instruments Div. of Stryker Corporation Right IBO Blade , for use with Stryker TPS Reciprocating Saw, REF 5100-37-901S2, Stryker Instruments, Kalamazoo, MI.
Product Usage: The intended use of these devices is to cut bone and hard tissue i Terminated |
DZJ | K040369 |
| Nov 16, 2011 | Stryker Instruments Div. of Stryker Corporation Right/Left IBO Blade Set, for use with Stryker TPS Reciprocating Saw, REF 5100-37-903, Stryker Instruments, Kalamazoo, MI.
Product Usage: The intended use of these devices is to cut bone and hard ti Terminated |
DZJ | K040369 |
| Nov 16, 2011 | Stryker Instruments Div. of Stryker Corporation IBO Blade, Left, for use with Stryker TPS Reciprocating Saw, REF 5100-37-902, Stryker Instruments, Kalamazoo, MI.
Product Usage: The intended use of these devices is to cut bone and hard tissue in Terminated |
DZJ | K040369 |
| Nov 16, 2011 | Stryker Instruments Div. of Stryker Corporation IBO Blade, Right, for use with Stryker TPS Reciprocating Saw, REF 5100-37-901, Stryker Instruments, Kalamazoo, MI.
Product Usage: The intended use of these devices is to cut bone and hard tissue in Terminated |
DZJ | K040369 |
| Mar 9, 2006 | Straumann Manufacturing Inc. Thermoplastic templates, free-end situation
Catalog Number: 040.527 Terminated |
DZJ | None listed |
| Mar 9, 2006 | Straumann Manufacturing Inc. Thermoplastic templates, single tooth
Catalog Number: 040.526 Terminated |
DZJ | None listed |
| Aug 23, 2005 | Stryker Instruments Div. of Stryker Corporation Stryker brand Consolidated Operating Room Equipment (CORE) SystemPowered Instrument Driver, REF 5400-50; Model 5400-050-000A. Terminated |
DZJ | K040369 |
| Aug 23, 2005 | Stryker Instruments Div. of Stryker Corporation Stryker brand Consolidated Operating Room Equipment (CORE) System Powered Instrument Driver, REF 5400-50; Model 5400-050-000. Terminated |
DZJ | K040369 |
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