510(k) K981194
K981194 is an FDA 510(k) premarket notification submitted by Nexa Orthopedics, Inc. for the device "FUTURA BIOMEDICAL FLEXIBLE GREAT TOE IMPLANT". The FDA issued a decision of Substantially Equivalent on June 30, 1998. The device falls under product code KWH (Prosthesis, Toe, Constrained, Polymer), a Class II device regulated under 21 CFR 888.3720. Nexa Orthopedics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 30, 1998
- Date Received
- April 2, 1998
- 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