510(k) K083651
K083651 is an FDA 510(k) premarket notification submitted by Encore Medical L.P. for the device "REVELATION STEM, MODEL 427-21/42-080/180". The FDA issued a decision of Substantially Equivalent on Mar 13, 2009. The device falls under product code KWA (Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)), a Class III device regulated under 21 CFR 888.3330. Encore Medical L.P. has 81 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 13, 2009
- Date Received
- Dec 9, 2008
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
- Device Class
- Class III
- Regulation Number
- 888.3330
- Review Panel
- OR
- Submission Type
- PMA