510(k) K072251
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 8, 2008
- Date Received
- August 13, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained
- Device Class
- Class U
- Regulation Number
- Review Panel
- OR
- Submission Type