510(k) K241599

Signature Osteosynthesis Plate System by Signature Orthopaedic Pty , Ltd. — Product Code HRS

K241599 is an FDA 510(k) premarket notification submitted by Signature Orthopaedic Pty , Ltd. for the device "Signature Osteosynthesis Plate System". The FDA issued a decision of Substantially Equivalent on February 6, 2025. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 6, 2025
Date Received
June 4, 2024
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