510(k) K941650
K941650 is an FDA 510(k) premarket notification submitted by Biomet, Inc. for the device "TOTAL TOE SYSTEM II". The FDA issued a decision of Substantially Equivalent on December 19, 1994. The device falls under product code LZJ (Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained), a Class U device. Biomet, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 19, 1994
- Date Received
- April 5, 1994
- 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