Clearance Summary
Memodyn Staple received FDA 510(k) clearance under submission number K161587, sponsored by Austin & Associates, Inc./Telos Medical Equipment. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2017-02-01.
- Submission: K161587
- Applicant / Sponsor: Austin & Associates, Inc./Telos Medical Equipment
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 2017-02-01
Classification & Regulation
This clearance is catalogued under FDA product code JDR and 21 CFR 888.3030, within the Orthopedic review panel as a Class II device.