510(k) K121544
K121544 is an FDA 510(k) premarket notification submitted by Wrightmedicaltechnologyinc for the device "DYNASTY BIOFOAM SHELL". The FDA issued a decision of Substantially Equivalent on Jul 30, 2012. 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. Wrightmedicaltechnologyinc has 301 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 30, 2012
- Date Received
- May 25, 2012
- 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