510(k) K101170
K101170 is an FDA 510(k) premarket notification submitted by Acute Innovations, LLC for the device "ACUTE INNOVATIONS STERNAL FIXATION SYSTEM". The FDA issued a decision of Substantially Equivalent on September 17, 2010. 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. Acute Innovations, LLC has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 17, 2010
- Date Received
- April 26, 2010
- 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