Clearance Summary
SIMPLEX ENHANCEMENT MIXER received FDA 510(k) clearance under submission number K853310, sponsored by Howmedica 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 1985-09-11.
- Submission: K853310
- Applicant / Sponsor: Howmedica Corp.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class I
- Regulation citation: 21 CFR 888.4210
- Decision date: 1985-09-11
Classification & Regulation
This clearance is catalogued under FDA product code JDZ and 21 CFR 888.4210, within the Orthopedic review panel as a Class I device.