510(k) K823405
K823405 is an FDA 510(k) premarket notification submitted by Zimmer, Inc. for the device "ZIMMER GREAT TOE". The FDA issued a decision of Substantially Equivalent on January 24, 1983. The device falls under product code KWH (Prosthesis, Toe, Constrained, Polymer), a Class II device regulated under 21 CFR 888.3720. Zimmer, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 24, 1983
- Date Received
- November 15, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Toe, Constrained, Polymer
- Device Class
- Class II
- Regulation Number
- 888.3720
- Review Panel
- OR
- Submission Type