Clearance Summary
REL-K ARTIFICAL LIMB PROSTHESIS received FDA 510(k) clearance under submission number K101859, sponsored by Rizzoli Ortopedica S.P.A.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2010-10-13.
- Submission: K101859
- Applicant / Sponsor: Rizzoli Ortopedica S.P.A.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.3420
- Decision date: 2010-10-13
Classification & Regulation
This clearance is catalogued under FDA product code ISY and 21 CFR 890.3420, within the Physical Medicine review panel as a Class I device.