Clearance Summary
Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds received FDA 510(k) clearance under submission number K240856, sponsored by Osartis GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2024-11-20.
- Submission: K240856
- Applicant / Sponsor: Osartis GmbH
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3027
- Decision date: 2024-11-20
Classification & Regulation
This clearance is catalogued under FDA product code MBB and 21 CFR 888.3027, within the Orthopedic review panel as a Class II device.