510(k) K050028
K050028 is an FDA 510(k) premarket notification submitted by Biomet Manufacturing, Inc. for the device "MAESTRO CARPAL HEMIARTHROPLASTY". The FDA issued a decision of Substantially Equivalent on March 25, 2005. The device falls under product code KWN (Prosthesis, Wrist, Carpal Lunate), a Class II device regulated under 21 CFR 888.3750. Biomet Manufacturing, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 25, 2005
- Date Received
- January 6, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Wrist, Carpal Lunate
- Device Class
- Class II
- Regulation Number
- 888.3750
- Review Panel
- OR
- Submission Type