510(k) K103497
K103497 is an FDA 510(k) premarket notification submitted by United Orthopedic Corp. for the device "CERAMIC FEMORAL HEAD". The FDA issued a decision of Substantially Equivalent on March 4, 2011. The device falls under product code MEH (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate), a Class II device regulated under 21 CFR 888.3353. United Orthopedic Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 4, 2011
- Date Received
- November 29, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
- Device Class
- Class II
- Regulation Number
- 888.3353
- Review Panel
- OR
- Submission Type