FDA.report

510(k) K231599

Device
Stryker MP, Mandible, HMMF and MMF AXS Screws
Applicant
Stryker Leibinger GmbH & Co KG
510(k) number
K231599
Product code
DZL
Decision
Substantially Equivalent (SESE)
Decision date
2023-08-24
Date received
2023-06-01
Regulation
872.4880
Classification name
Screw, Fixation, Intraosseous
Medical specialty
Dental
Review panel
Dental
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
Amelia Kesti
Address
Boetzinger Strasse 41 D-79111 Freiburg DE

FDA Registration Numbers

Source Documents

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

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