Clearance Summary
SECTRA ORTHOPEDIC PACKAGE received FDA 510(k) clearance under submission number K031590, sponsored by Sectra-Imtec AB. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2003-10-02.
- Submission: K031590
- Applicant / Sponsor: Sectra-Imtec AB
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 2003-10-02
Classification & Regulation
This clearance is catalogued under FDA product code LLZ and 21 CFR 892.2050, within the Radiology review panel as a Class II device.