510(k) K032303 ยท HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM
| Applicant | Stryker Instruments, Kalamazoo MI, US |
| Decision | Substantially Equivalent, Jan 16, 2004 |
| Received | Jul 25, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K032303
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 14, 2011 | Stryker Instruments Division of Stryker Corporation Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their accessories.
These burs are intended for use during various surgical procedures to cut hard tissue or bone Terminated |
HBE | None listed |
| Feb 14, 2011 | Stryker Instruments Division of Stryker Corporation Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their accessories.
These burs are intended for use during various surgical procedures to cut hard tissue or bone Terminated |
HBE | None listed |
| Feb 14, 2011 | Stryker Instruments Division of Stryker Corporation Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their accessories.
These burs are intended for use during various surgical procedures to cut hard tissue or bone Terminated |
HBE | None listed |
| Feb 14, 2011 | Stryker Instruments Division of Stryker Corporation Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their accessories.
These burs are intended for use during various surgical procedures to cut hard tissue or bone Terminated |
HBE | None listed |
| Feb 14, 2011 | Stryker Instruments Division of Stryker Corporation Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their accessories.
These burs are intended for use during various surgical procedures to cut hard tissue or bone Terminated |
HBE | None listed |
| Feb 14, 2011 | Stryker Instruments Division of Stryker Corporation Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their accessories.
These burs are intended for use during various surgical procedures to cut hard tissue or bone a Terminated |
HBE | None listed |
| Feb 14, 2011 | Stryker Instruments Division of Stryker Corporation Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their accessories.
These burs are intended for use during various surgical procedures to cut hard tissue or bone Terminated |
HBE | None listed |
| Feb 14, 2011 | Stryker Instruments Division of Stryker Corporation Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their accessories.
These burs are intended for use during various surgical procedures to cut hard tissue or bone Terminated |
HBE | None listed |
| Feb 14, 2011 | Stryker Instruments Division of Stryker Corporation Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their accessories.
These burs are intended for use during various surgical procedures to cut hard tissue or bone Terminated |
HBE | None listed |
| Feb 14, 2011 | Stryker Instruments Division of Stryker Corporation Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their accessories.
These burs are intended for use during various surgical procedures to cut hard tissue or bone Terminated |
HBE | None listed |
| Feb 14, 2011 | Stryker Instruments Division of Stryker Corporation Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their accessories.
These burs are intended for use during various surgical procedures to cut hard tissue or bone Terminated |
HBE | None listed |
| Feb 14, 2011 | Stryker Instruments Division of Stryker Corporation Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their accessories.
These burs are intended for use during various surgical procedures to cut hard tissue or bone Terminated |
HBE | None listed |
| Feb 14, 2011 | Stryker Instruments Division of Stryker Corporation Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their accessories.
These burs are intended for use during various surgical procedures to cut hard tissue or bone Terminated |
HBE | None listed |
| Jan 11, 2010 | Stryker Instruments Div. of Stryker Corporation Stryker MIS Bur, 2.0mm Neuro Diamond, sterile, Stryker Instruments, Kalamazoo, MI; REF 8420-107-120. Terminated |
HBE | None listed |
| Jan 11, 2010 | Stryker Instruments Div. of Stryker Corporation Stryker MIS Bur, 2.5mm Neuro Diamond, sterile, Stryker Instruments, Kalamazoo, MI; REF 8420-107-125. Terminated |
HBE | None listed |
| Jan 11, 2010 | Stryker Instruments Div. of Stryker Corporation Stryker MIS Bur, 3.0mm Neuro Diamond, sterile, Stryker Instruments, Kalamazoo, MI; REF 8420-107-130. Terminated |
HBE | None listed |
| Jan 11, 2010 | Stryker Instruments Div. of Stryker Corporation Stryker MIS Bur, 3.5mm Neuro Diamond, sterile, Stryker Instruments, Kalamazoo, MI; REF 8420-107-135. Terminated |
HBE | None listed |
| Jan 11, 2010 | Stryker Instruments Div. of Stryker Corporation Stryker MIS Bur, 3.0mm Neuro Diamond Course, sterile, Stryker Instruments, Kalamazoo, MI; REF 8420-107-230. Terminated |
HBE | None listed |
| Apr 22, 2008 | Stryker Instruments Div. of Stryker Corporation Stryker Round Fluted Bur (6.0mm) Extra-Long for use with TPS Universal Drill Extra Long "R" Attachment, sterile, Stryker Instruments, Kalamazoo, MI; REF 5160-10-60. Terminated |
HBE | None listed |
| Apr 22, 2008 | Stryker Instruments Div. of Stryker Corporation Stryker Round Fluted Bur (7.6 mm) Extra Long for use with TPS Universal Drill Extra Long "R" Attachment, sterile, Stryker Instruments, Kalamazoo, MI; REF 5160-10-75. Terminated |
HBE | None listed |
| Apr 22, 2008 | Stryker Instruments Div. of Stryker Corporation Stryker Round Fluted Bur (9.1 mm) Extra Long for use with TPS Universal Drill Extra Long "R" Attachment, sterile, Stryker Instruments, Kalamazoo, MI; REF 5160-10-90. Terminated |
HBE | None listed |
| Apr 22, 2008 | Stryker Instruments Div. of Stryker Corporation Stryker 4.7 x 7.9 mm Fluted Drum, Extra Long for use with TPS Universal Drill Extra Long "R" Attachment, sterile, Stryker Instruments, Kalamazoo, MI; REF 5160-20-47. Terminated |
HBE | None listed |
| Apr 22, 2008 | Stryker Instruments Div. of Stryker Corporation Stryker 6.0 x 7.9 mm Fluted Drum, Extra Long for use with TPS Universal Drill Extra Long "R" Attachment, sterile, Stryker Instruments, Kalamazoo, MI; REF 5160-20-60. Terminated |
HBE | None listed |
| Apr 22, 2008 | Stryker Instruments Div. of Stryker Corporation Stryker 10.5 x 10.7 mm Fluted Drum, Extra Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5160-20-105. Terminated |
HBE | None listed |
| Apr 22, 2008 | Stryker Instruments Div. of Stryker Corporation Stryker 12.3 x 10.7 mm Fluted Drum, Extra Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5160-20-123. Terminated |
HBE | None listed |
| Apr 22, 2008 | Stryker Instruments Div. of Stryker Corporation Stryker 7.5 x 7.9 mm Fluted Drum, Extra Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5160-20-775. Terminated |
HBE | None listed |
| Apr 22, 2008 | Stryker Instruments Div. of Stryker Corporation Stryker 6.1 x 8.0 mm Acorn Bur, Extra long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5160-30-60. Terminated |
HBE | None listed |
| Apr 22, 2008 | Stryker Instruments Div. of Stryker Corporation Stryker 7.5 x 9.5 mm Acorn Bur, Extra long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5160-30-75. Terminated |
HBE | None listed |
| Apr 22, 2008 | Stryker Instruments Div. of Stryker Corporation Stryker 9.1 x 11.4 mm Acorn Bur, Extra Long, Stryker Instruments, Kalamazoo, MI; REF 5160-30-90. Terminated |
HBE | None listed |
| Apr 22, 2008 | Stryker Instruments Div. of Stryker Corporation Stryker 3.1 mm x 19.1 mm Straight Router, Extra Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5160-70-31. Terminated |
HBE | None listed |
| Apr 22, 2008 | Stryker Instruments Div. of Stryker Corporation Stryker Tapered Router Extra Long (2.3mm x 22.0mm) for use with extra long "R" Attachments, sterile, Stryker Instruments, Kalamazoo, MI; REF 5160-71-223. Terminated |
HBE | None listed |
| Apr 22, 2008 | Stryker Instruments Div. of Stryker Corporation Stryker 2.0 mm x 3.8 mm Neuro Drill, Extra Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5160-107-30. Terminated |
HBE | None listed |
| Apr 22, 2008 | Stryker Instruments Div. of Stryker Corporation Stryker 3.0mm Round Fluted Bur, Super Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-10-30. Terminated |
HBE | None listed |
| Apr 22, 2008 | Stryker Instruments Div. of Stryker Corporation Stryker 4.0mm Round Fluted Bur, Super Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-10-40. Terminated |
HBE | None listed |
| Apr 22, 2008 | Stryker Instruments Div. of Stryker Corporation Stryker 5.0mm Round Fluted Bur,Super Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-10-50. Terminated |
HBE | None listed |
| Apr 22, 2008 | Stryker Instruments Div. of Stryker Corporation Stryker 6.0mm Round Fluted Bur, Super Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-10-60. Terminated |
HBE | None listed |
| Apr 22, 2008 | Stryker Instruments Div. of Stryker Corporation Stryker 7.0mm Round Fluted Bur, Super Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-10-70. Terminated |
HBE | None listed |
| Apr 22, 2008 | Stryker Instruments Div. of Stryker Corporation Stryker 8.0mm Round Fluted Bur, Super Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-10-80. Terminated |
HBE | None listed |
| Apr 22, 2008 | Stryker Instruments Div. of Stryker Corporation Stryker 9.0mm Round Fluted Bur, Super Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-10-90. Terminated |
HBE | None listed |
| Apr 22, 2008 | Stryker Instruments Div. of Stryker Corporation Stryker 10.0 mm Round Fluted Bur, Super Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-10-100. Terminated |
HBE | None listed |
| Apr 22, 2008 | Stryker Instruments Div. of Stryker Corporation Stryker 4.0mm XX Coarse Round Diamond Bur, Super Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-13-140. Terminated |
HBE | None listed |
| Apr 22, 2008 | Stryker Instruments Div. of Stryker Corporation Stryker 5.0 mm XX Coarse Round Diamond Bur, Super Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-13-150. Terminated |
HBE | None listed |
| Apr 22, 2008 | Stryker Instruments Div. of Stryker Corporation Stryker 6mm XX Coarse Round Diamond Bur, Super Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-13-160. Terminated |
HBE | None listed |
| Apr 22, 2008 | Stryker Instruments Div. of Stryker Corporation Stryker Instruments 7.0mm XX Coarse Round Diamond Bur, Super Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-13-170. Terminated |
HBE | None listed |
| Apr 22, 2008 | Stryker Instruments Div. of Stryker Corporation Stryker Instruments 8.omm XX Coarse Round Diamond Bur, Super Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-13-180. Terminated |
HBE | None listed |
| Apr 22, 2008 | Stryker Instruments Div. of Stryker Corporation Stryker 6.0 mm Barrel Bur, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-17-60. Terminated |
HBE | None listed |
| Apr 22, 2008 | Stryker Instruments Div. of Stryker Corporation Stryker 4.7mm x 7.9mm Fluted Drum, Super Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-20-47. Terminated |
HBE | None listed |
| Apr 22, 2008 | Stryker Instruments Div. of Stryker Corporation Stryker 6.0mm x 7.9 mm Bur, Super Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-20-60. Terminated |
HBE | None listed |
| Apr 22, 2008 | Stryker Instruments Div. of Stryker Corporation Stryker 10.5mm x 10.7mm Fluted Drum, Super Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-20-105. Terminated |
HBE | None listed |
| Apr 22, 2008 | Stryker Instruments Div. of Stryker Corporation Stryker 12.3mm x 10.7mm Fluted Drum, Super Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-20-123. Terminated |
HBE | None listed |
| Apr 22, 2008 | Stryker Instruments Div. of Stryker Corporation Stryker 7.8mm x 7.9mm Fluted Drum, Super Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-20-775. Terminated |
HBE | None listed |
| Apr 22, 2008 | Stryker Instruments Div. of Stryker Corporation Stryker 9.1mm x 7.9mm Fluted Drum, Super Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-20-991. Terminated |
HBE | None listed |
| Apr 22, 2008 | Stryker Instruments Div. of Stryker Corporation Stryker 7.5mm x 7.9mm XX Coarse Diamond Drum, Super Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-21-775. Terminated |
HBE | None listed |
| Apr 22, 2008 | Stryker Instruments Div. of Stryker Corporation Stryker 9.1mm x 7.9mm XX Coarse Diamond Drum, Super Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-21-991. Terminated |
HBE | None listed |
| Apr 22, 2008 | Stryker Instruments Div. of Stryker Corporation Stryker 6.0mm x 8.0mm Acorn Bur, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-30-60. Terminated |
HBE | None listed |
| Apr 22, 2008 | Stryker Instruments Div. of Stryker Corporation Stryker 7.5mm x 9.5mm Acorn Bur, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-30-75. Terminated |
HBE | None listed |
| Apr 22, 2008 | Stryker Instruments Div. of Stryker Corporation Stryker 9.0mm x 11.4mm Acorn Bur, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-30-90. Terminated |
HBE | None listed |
| Apr 22, 2008 | Stryker Instruments Div. of Stryker Corporation Stryker 3.1mm x 19.1mm Straight Router, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-70-31. Terminated |
HBE | None listed |
| Apr 22, 2008 | Stryker Instruments Div. of Stryker Corporation Stryker 3.0mm x 34.9mm Straight Router, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-70-230. Terminated |
HBE | None listed |
| Apr 22, 2008 | Stryker Instruments Div. of Stryker Corporation Stryker 32.mm x 18.3mm Heliocoidal Rasp Super Long, for use with "RX" attachments, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-80-30. Terminated |
HBE | None listed |
| Apr 22, 2008 | Stryker Instruments Div. of Stryker Corporation Stryker 3.0mm x 3.8mm Precision Neuro Drill Extended Long for use with Long "AM" attachments, sterile, Stryker Instruments, Kalamazoo, MI; REF 5230-107-530S1. Terminated |
HBE | None listed |
| Apr 22, 2008 | Stryker Instruments Div. of Stryker Corporation Stryker 5.0mm Round Fluted Bur, Extra Long, for use with TPS Universal Drill Extra Long "R" attachment, sterile, Stryker Instruments, Kalamazoo, MI; REF 5260-10-50. Terminated |
HBE | None listed |
| Apr 22, 2008 | Stryker Instruments Div. of Stryker Corporation Stryker Instruments 6.5mm Round Fluted Bur Extra Long for use with TPS Universal Drill Extra Long "R" attachment, sterile, Stryker Instruments, Kalamazoo, MI; REF 5260-10-65. Terminated |
HBE | None listed |
| Apr 22, 2008 | Stryker Instruments Div. of Stryker Corporation Stryker Instruments 7.0mm Round Fluted Bur Extra Long, for use with TPS Universal Drill Extra Long "R" attachment, sterile, Stryker Instruments, Kalamazoo, MI; REF 5260-10-70. Terminated |
HBE | None listed |
| Apr 22, 2008 | Stryker Instruments Div. of Stryker Corporation Stryker Instruments Minor modification product, 550-19-20 with 304.8mm length, sterile, product of Ireland, Stryker Instruments, Kalamazoo, MI; REF 5500019020S3. Terminated |
HBE | None listed |
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