510(k) K880156
K880156 is an FDA 510(k) premarket notification submitted by Biomet, Inc. for the device "VOLZ TOTAL WRIST PROSTHESIS". The FDA issued a decision of Substantially Equivalent on February 17, 1988. The device falls under product code KWM (Prosthesis, Wrist, Semi-Constrained), a Class II device regulated under 21 CFR 888.3800. Biomet, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 17, 1988
- Date Received
- January 13, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Wrist, Semi-Constrained
- Device Class
- Class II
- Regulation Number
- 888.3800
- Review Panel
- OR
- Submission Type