Clearance Summary
Juveno Hip System Femoral Stem, b-ONE Primary Acetabular System Cups received FDA 510(k) clearance under submission number K182705, sponsored by B-One Ortho, Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2019-02-14.
- Submission: K182705
- Applicant / Sponsor: B-One Ortho, Corp.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3353
- Decision date: 2019-02-14
Classification & Regulation
This clearance is catalogued under FDA product code LZO and 21 CFR 888.3353, within the Orthopedic review panel as a Class II device.