510(k) K051836
Clearance Details
- Decision
- SESU ()
- Decision Date
- November 21, 2005
- Date Received
- July 6, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Hip, Cement Restrictor
- Device Class
- Class II
- Regulation Number
- 878.3300
- Review Panel
- OR
- Submission Type