Atlas FDA

STYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM

FDA 510(k) clearance K112593 · decided 2012-05-01

Clearance details

K-number
K112593
Device name
STYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM
Applicant
Stryker Corporation
Decision
Substantially Equivalent
Date received
2011-09-07
Decision date
2012-05-01
Days to decision
237 days
Clearance type
Traditional
Product code
ERL
Device class
2
Regulation number
874.4250
Medical specialty
Ear, Nose, Throat
Advisory committee
Ear, Nose, Throat
Location
Kalamazoo, MI, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
BRAUN-CUTTER TRAPEZO-METACARPAL PROSTHESIS (P960053/S005)Stryker Corporation2016-08-09
SBI BRAUN-CUTTER TRAPEZ-METACARPAL PROSTHESIS (P960053/S004)Stryker Corporation2007-09-28
BRAUN-CUTTER TRAPEZO-METACARPAL PROSTHESIS (P960053/S003)Stryker Corporation2002-12-31
TOTAL TRAPEZIO METACARPAL PROSTHESIS (P960053/S002)Stryker Corporation1998-06-04
TOTAL TRAPEZIO METACARPAL PROSTHESIS (P960053/S001)Stryker Corporation1998-06-04
BRAUN-CUTTER TRAPEZO-METACARPAL PROSTHESIS (P960053)Stryker Corporation1997-06-19