Clearance Summary
Materialise PKA Guide System received FDA 510(k) clearance under submission number K202207, sponsored by Materialise NV. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2020-10-02.
- Submission: K202207
- Applicant / Sponsor: Materialise NV
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3520
- Decision date: 2020-10-02
Classification & Regulation
This clearance is catalogued under FDA product code HSX and 21 CFR 888.3520, within the Orthopedic review panel as a Class II device.