510(k) K081448
K081448 is an FDA 510(k) premarket notification submitted by Encore Medical L.P. for the device "ENCORE SHOULDER REVISION GLENOID". The FDA issued a decision of Substantially Equivalent on Sep 30, 2008. The device falls under product code MBF (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented), a Class II device regulated under 21 CFR 888.3670. Encore Medical L.P. has 81 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 30, 2008
- Date Received
- May 23, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
- Device Class
- Class II
- Regulation Number
- 888.3670
- Review Panel
- OR
- Submission Type
- 510(k)