K242445
- 510(k) number
- K242445
- Device name
- Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea Tibia Plating System
- Applicant
- Stryker GmbH CH
- Product code
- HRS — Plate, Fixation, Bone
- Decision date
- 2024-10-06
- Date received
- 2024-08-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K242445.pdf
Official FDA record: K242445
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.