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510(k) K912190

Device
STRYKER HIGH VACUUM BONE CEMENT MIXER/INJECT SYST
Applicant
STRYKER CORP.
510(k) number
K912190
Product code
JDZ  
Decision
Substantially Equivalent (SESE)
Decision date
1991-08-29
Date received
1991-05-17
Regulation
888.4210
Classification name
Mixer, Cement, For Clinical Use
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
HARMON H WOODWORTH
Address
P.O. Box 4085 Kalamazoo MI US 49003 49003

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JDZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K934253EXACTECH ALL POLY ACETABULAR CUPExactech, Inc.1994-04-29
K925025PRISM BONE CEMENT MIXING SYSTEMDepuy, Inc.1994-01-05
K892937REUSABLE BOWL AND SPATULA FOR MIXING BONE CEMENTSDentsply Intl.1989-06-22
K861086ZIMMER VACUUM MIXING SYSTEMZimmer, Inc.1986-04-14
K854077MIX EVAC IIStryker Corp.1986-01-31
K853310SIMPLEX ENHANCEMENT MIXERHowmedica Corp.1985-09-11
K851205CEMENTRIFUGEBiodynamic Technologies, Inc.1985-07-16
K843219ZIMMER BONE CEMENT CENTRIFUGATION SYSZimmer, Inc.1984-11-29
K792186HOWMEDICA MIX-KIT IIHowmedica Corp.1979-12-05
K780857MIXING BOWL & SPATULA, DISPOSABLEHowmedica Corp.1978-06-13
K760617MIX EVAC BONE CEMENTStryker Corp.1976-10-05
K760636ORTHOMIXDiemolding Corp.1976-10-05

Legacy Summary#

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FDA Review#

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