Clearance Summary
REVERSE SHOULDER PROSTHESIS MONOBLOCK STEM, REVERSE SHOULDER PROSTHESIS HUMERAL INSERTS, MODEL 510-00-006/012 received FDA 510(k) clearance under submission number K100741, sponsored by Encore Medical L.P.. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2010-08-02.
- Submission: K100741
- Applicant / Sponsor: Encore Medical L.P.
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3660
- Decision date: 2010-08-02
Classification & Regulation
This clearance is catalogued under FDA product code PHX and 21 CFR 888.3660, within the Orthopedic review panel as a Class II device.