510(k) K223772

PRO Plating System, Stryker Trauma Pelvic Set (Matta) by Stryker GmbH — Product Code HRS

K223772 is an FDA 510(k) premarket notification submitted by Stryker GmbH for the device "PRO Plating System, Stryker Trauma Pelvic Set (Matta)". The FDA issued a decision of Substantially Equivalent on April 7, 2023. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Stryker GmbH has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 7, 2023
Date Received
December 16, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type