510(k) K920446
K920446 is an FDA 510(k) premarket notification submitted by Biomet, Inc. for the device "TOTAL TOE SYSTEM". The FDA issued a decision of Substantially Equivalent on March 22, 1993. 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
- March 22, 1993
- Date Received
- February 4, 1992
- 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