510(k) K190290
K190290 is an FDA 510(k) premarket notification submitted by Encore Medical L.P. for the device "AltiVate Reverse Humeral Stem, 48mm". The FDA issued a decision of Substantially Equivalent on April 26, 2019. The device falls under product code KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented), a Class II device regulated under 21 CFR 888.3660. Encore Medical L.P. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 26, 2019
- Date Received
- February 11, 2019
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
- Device Class
- Class II
- Regulation Number
- 888.3660
- Review Panel
- OR
- Submission Type