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510(k) K183172

Device
Stryker SternalPlate System
Applicant
Stryker
510(k) number
K183172
Product code
HRS  
Decision
Substantially Equivalent (SESE)
Decision date
2019-03-05
Date received
2018-11-16
Regulation
888.3030
Classification name
Plate, Fixation, Bone
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Hans Geiger
Address
750 Trade Centre Way Suite 200 Portage MI US 49002 49002

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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