510(k) K080402
K080402 is an FDA 510(k) premarket notification submitted by Encore Medical L.P. for the device "ENCORE SHOULDER PRIMARY HUMERAL STEM, MODEL 500-00, ENCORE SHOULDER HUMERAL HEAD, MODEL 520-38". The FDA issued a decision of Substantially Equivalent on Mar 28, 2008. 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
- Mar 28, 2008
- Date Received
- Feb 14, 2008
- Clearance Type
- Traditional
- 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)