510(k) K112345
K112345 is an FDA 510(k) premarket notification submitted by Medos International SARL for the device "DISTAL VOLAR RADIUS PLATING SYSTEMS". The FDA issued a decision of Substantially Equivalent on October 31, 2011. The device falls under product code LXT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite), a Class II device regulated under 21 CFR 888.3030. Medos International SARL has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 31, 2011
- Date Received
- August 15, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type