510(k) K111145
K111145 is an FDA 510(k) premarket notification submitted by Medacta International for the device "ENDO HEAD". The FDA issued a decision of Substantially Equivalent on August 16, 2011. The device falls under product code LZY (Prosthesis, Hip, Hemi-, Femoral, Metal Ball), a Class II device regulated under 21 CFR 888.3360. Medacta International has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 16, 2011
- Date Received
- April 22, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Hip, Hemi-, Femoral, Metal Ball
- Device Class
- Class II
- Regulation Number
- 888.3360
- Review Panel
- OR
- Submission Type