FDA.report

510(k) K223294

Device
SpineJack® Expansion Kit
Applicant
Stryker Instruments
510(k) number
K223294
Product code
NDN
Decision
Substantially Equivalent (SESE)
Decision date
2022-12-20
Date received
2022-10-26
Regulation
888.3027
Classification name
Cement, Bone, Vertebroplasty
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Bruce Backlund
Address
1941 Stryker Way Portage MI US 49002 49002

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

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