510(k) K092331
K092331 is an FDA 510(k) premarket notification submitted by Encore Medical L.P. for the device "DJO SURGICAL REVISION FEMORAL HIP SYSTEM, MODEL 428-14/24-140/200; 428-00-050/110;". The FDA issued a decision of Substantially Equivalent on Mar 3, 2010. 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 3, 2010
- Date Received
- Aug 4, 2009
- Clearance Type
- Traditional
- 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