510(k) K040369 ยท DZJ Driver, Wire, And Bone Drill, Manual
STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM
| Applicant | Stryker Instruments, Kalamazoo MI, US |
| Decision | Substantially Equivalent, Apr 1, 2004 |
| Received | Feb 13, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K040369
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| Nov 16, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker Instruments 2.1 mm Cross-Cut Fissure Bur, carbide extended, sterile; REF 2296-101-621. Terminated |
DZI | None listed |
| 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 | 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.