Clearance Summary
Exactech® Novation® Element Press-fit Femoral Stem received FDA 510(k) clearance under submission number K153649, sponsored by Exactech, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2016-08-31.
- Submission: K153649
- Applicant / Sponsor: Exactech, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3353
- Decision date: 2016-08-31
Classification & Regulation
This clearance is catalogued under FDA product code MEH and 21 CFR 888.3353, within the Orthopedic review panel as a Class II device.