Atlas FDA

STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM

FDA 510(k) clearance K032303 · decided 2004-01-16

Clearance details

K-number
K032303
Device name
STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM
Applicant
Stryker Instruments
Decision
Substantially Equivalent
Date received
2003-07-25
Decision date
2004-01-16
Days to decision
175 days
Clearance type
Traditional
Product code
HBE
Device class
2
Regulation number
882.4310
Medical specialty
Neurology
Advisory committee
Neurology
Location
Kalamazoo, MI, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their a recall (Z-1232-2011)Stryker Instruments Division of Stryker Corporation2011-02-14
Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their a recall (Z-1233-2011)Stryker Instruments Division of Stryker Corporation2011-02-14
Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their a recall (Z-1234-2011)Stryker Instruments Division of Stryker Corporation2011-02-14
Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their a recall (Z-1235-2011)Stryker Instruments Division of Stryker Corporation2011-02-14
Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their a recall (Z-1236-2011)Stryker Instruments Division of Stryker Corporation2011-02-14
Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their a recall (Z-1237-2011)Stryker Instruments Division of Stryker Corporation2011-02-14
Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their a recall (Z-1238-2011)Stryker Instruments Division of Stryker Corporation2011-02-14
Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their a recall (Z-1239-2011)Stryker Instruments Division of Stryker Corporation2011-02-14
Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their a recall (Z-1240-2011)Stryker Instruments Division of Stryker Corporation2011-02-14
Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their a recall (Z-1241-2011)Stryker Instruments Division of Stryker Corporation2011-02-14
Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their a recall (Z-1242-2011)Stryker Instruments Division of Stryker Corporation2011-02-14
Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their a recall (Z-1243-2011)Stryker Instruments Division of Stryker Corporation2011-02-14
Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their a recall (Z-1244-2011)Stryker Instruments Division of Stryker Corporation2011-02-14
Stryker MIS Bur, 2.0mm Neuro Diamond, sterile, Stryker Instruments, Kalamazoo, MI; REF 842 recall (Z-0595-2010)Stryker Instruments Div. of Stryker Corporation2010-01-11
Stryker MIS Bur, 2.5mm Neuro Diamond, sterile, Stryker Instruments, Kalamazoo, MI; REF 842 recall (Z-0596-2010)Stryker Instruments Div. of Stryker Corporation2010-01-11
Stryker MIS Bur, 3.0mm Neuro Diamond, sterile, Stryker Instruments, Kalamazoo, MI; REF 842 recall (Z-0597-2010)Stryker Instruments Div. of Stryker Corporation2010-01-11
Stryker MIS Bur, 3.5mm Neuro Diamond, sterile, Stryker Instruments, Kalamazoo, MI; REF 842 recall (Z-0598-2010)Stryker Instruments Div. of Stryker Corporation2010-01-11
Stryker MIS Bur, 3.0mm Neuro Diamond Course, sterile, Stryker Instruments, Kalamazoo, MI; recall (Z-0599-2010)Stryker Instruments Div. of Stryker Corporation2010-01-11
Stryker Round Fluted Bur (6.0mm) Extra-Long for use with TPS Universal Drill Extra Long "R recall (Z-0988-2008)Stryker Instruments Div. of Stryker Corporation2008-04-22
Stryker Round Fluted Bur (7.6 mm) Extra Long for use with TPS Universal Drill Extra Long " recall (Z-0989-2008)Stryker Instruments Div. of Stryker Corporation2008-04-22
Stryker Round Fluted Bur (9.1 mm) Extra Long for use with TPS Universal Drill Extra Long " recall (Z-0990-2008)Stryker Instruments Div. of Stryker Corporation2008-04-22
Stryker 4.7 x 7.9 mm Fluted Drum, Extra Long for use with TPS Universal Drill Extra Long " recall (Z-0991-2008)Stryker Instruments Div. of Stryker Corporation2008-04-22
Stryker 6.0 x 7.9 mm Fluted Drum, Extra Long for use with TPS Universal Drill Extra Long " recall (Z-0992-2008)Stryker Instruments Div. of Stryker Corporation2008-04-22
Stryker 10.5 x 10.7 mm Fluted Drum, Extra Long, sterile, Stryker Instruments, Kalamazoo, M recall (Z-0993-2008)Stryker Instruments Div. of Stryker Corporation2008-04-22
Stryker 12.3 x 10.7 mm Fluted Drum, Extra Long, sterile, Stryker Instruments, Kalamazoo, M recall (Z-0994-2008)Stryker Instruments Div. of Stryker Corporation2008-04-22
Stryker 7.5 x 7.9 mm Fluted Drum, Extra Long, sterile, Stryker Instruments, Kalamazoo, MI; recall (Z-0995-2008)Stryker Instruments Div. of Stryker Corporation2008-04-22
Stryker 6.1 x 8.0 mm Acorn Bur, Extra long, sterile, Stryker Instruments, Kalamazoo, MI; R recall (Z-0996-2008)Stryker Instruments Div. of Stryker Corporation2008-04-22
Stryker 7.5 x 9.5 mm Acorn Bur, Extra long, sterile, Stryker Instruments, Kalamazoo, MI; R recall (Z-0997-2008)Stryker Instruments Div. of Stryker Corporation2008-04-22
Stryker 9.1 x 11.4 mm Acorn Bur, Extra Long, Stryker Instruments, Kalamazoo, MI; REF 5160- recall (Z-0998-2008)Stryker Instruments Div. of Stryker Corporation2008-04-22
Stryker 3.1 mm x 19.1 mm Straight Router, Extra Long, sterile, Stryker Instruments, Kalama recall (Z-0999-2008)Stryker Instruments Div. of Stryker Corporation2008-04-22
Stryker Tapered Router Extra Long (2.3mm x 22.0mm) for use with extra long "R" Attachments recall (Z-1000-2008)Stryker Instruments Div. of Stryker Corporation2008-04-22
Stryker 2.0 mm x 3.8 mm Neuro Drill, Extra Long, sterile, Stryker Instruments, Kalamazoo, recall (Z-1001-2008)Stryker Instruments Div. of Stryker Corporation2008-04-22
Stryker 3.0mm Round Fluted Bur, Super Long, sterile, Stryker Instruments, Kalamazoo, MI; R recall (Z-1002-2008)Stryker Instruments Div. of Stryker Corporation2008-04-22
Stryker 4.0mm Round Fluted Bur, Super Long, sterile, Stryker Instruments, Kalamazoo, MI; R recall (Z-1003-2008)Stryker Instruments Div. of Stryker Corporation2008-04-22
Stryker 5.0mm Round Fluted Bur,Super Long, sterile, Stryker Instruments, Kalamazoo, MI; RE recall (Z-1004-2008)Stryker Instruments Div. of Stryker Corporation2008-04-22
Stryker 6.0mm Round Fluted Bur, Super Long, sterile, Stryker Instruments, Kalamazoo, MI; R recall (Z-1005-2008)Stryker Instruments Div. of Stryker Corporation2008-04-22
Stryker 7.0mm Round Fluted Bur, Super Long, sterile, Stryker Instruments, Kalamazoo, MI; R recall (Z-1006-2008)Stryker Instruments Div. of Stryker Corporation2008-04-22
Stryker 8.0mm Round Fluted Bur, Super Long, sterile, Stryker Instruments, Kalamazoo, MI; R recall (Z-1007-2008)Stryker Instruments Div. of Stryker Corporation2008-04-22
Stryker 9.0mm Round Fluted Bur, Super Long, sterile, Stryker Instruments, Kalamazoo, MI; R recall (Z-1008-2008)Stryker Instruments Div. of Stryker Corporation2008-04-22
Stryker 10.0 mm Round Fluted Bur, Super Long, sterile, Stryker Instruments, Kalamazoo, MI; recall (Z-1009-2008)Stryker Instruments Div. of Stryker Corporation2008-04-22
Stryker 4.0mm XX Coarse Round Diamond Bur, Super Long, sterile, Stryker Instruments, Kalam recall (Z-1010-2008)Stryker Instruments Div. of Stryker Corporation2008-04-22
Stryker 5.0 mm XX Coarse Round Diamond Bur, Super Long, sterile, Stryker Instruments, Kala recall (Z-1011-2008)Stryker Instruments Div. of Stryker Corporation2008-04-22
Stryker 6mm XX Coarse Round Diamond Bur, Super Long, sterile, Stryker Instruments, Kalamaz recall (Z-1012-2008)Stryker Instruments Div. of Stryker Corporation2008-04-22
Stryker Instruments 7.0mm XX Coarse Round Diamond Bur, Super Long, sterile, Stryker Instru recall (Z-1013-2008)Stryker Instruments Div. of Stryker Corporation2008-04-22
Stryker Instruments 8.omm XX Coarse Round Diamond Bur, Super Long, sterile, Stryker Instru recall (Z-1014-2008)Stryker Instruments Div. of Stryker Corporation2008-04-22
Stryker 6.0 mm Barrel Bur, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-17-60. recall (Z-1015-2008)Stryker Instruments Div. of Stryker Corporation2008-04-22
Stryker 4.7mm x 7.9mm Fluted Drum, Super Long, sterile, Stryker Instruments, Kalamazoo, MI recall (Z-1016-2008)Stryker Instruments Div. of Stryker Corporation2008-04-22
Stryker 6.0mm x 7.9 mm Bur, Super Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5 recall (Z-1017-2008)Stryker Instruments Div. of Stryker Corporation2008-04-22
Stryker 10.5mm x 10.7mm Fluted Drum, Super Long, sterile, Stryker Instruments, Kalamazoo, recall (Z-1018-2008)Stryker Instruments Div. of Stryker Corporation2008-04-22
Stryker 12.3mm x 10.7mm Fluted Drum, Super Long, sterile, Stryker Instruments, Kalamazoo, recall (Z-1019-2008)Stryker Instruments Div. of Stryker Corporation2008-04-22