510(k) K090063
K090063 is an FDA 510(k) premarket notification submitted by Merete Medical, Inc. for the device "MERETE LOCKING BONE PLATE SYSTEM". The FDA issued a decision of Substantially Equivalent on April 22, 2009. The device falls under product code KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component), a Class II device regulated under 21 CFR 888.3030. Merete Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 22, 2009
- Date Received
- January 9, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type