510(k) K123982
K123982 is an FDA 510(k) premarket notification submitted by Encore Medical L.P. for the device "TURON GLENOID PEGGED, E+, TURON KEELED GLENOID, E+". The FDA issued a decision of Substantially Equivalent on Jan 23, 2013. 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 81 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 23, 2013
- Date Received
- Dec 26, 2012
- 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
- 510(k)