FDA.reportPublic FDA data

510(k) K222309

Device
Gamma4 System
Applicant
Stryker GmbH
510(k) number
K222309
Product code
HSB
Decision
Substantially Equivalent (SESE)
Decision date
2022-11-15
Date received
2022-08-01
Regulation
888.3020
Classification name
Rod, Fixation, Intramedullary And Accessories
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Cindy Leon
Address
325 Corporate Dr. Mahwah NJ US 07430 07430

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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