510(k) K113318
K113318 is an FDA 510(k) premarket notification submitted by Acute Innovations, LLC for the device "ACUTE INNOVATIONS MODULAR RIBLOC SYSTEM". The FDA issued a decision of Substantially Equivalent on January 12, 2012. The device falls under product code HRS (Plate, Fixation, Bone), 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
- January 12, 2012
- Date Received
- November 10, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plate, Fixation, Bone
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type