ACUTE Innovations, LLC
FDA Regulatory Profile
ACUTE Innovations, LLC appears in FDA public data with 1 recall, 5 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0852-2014, Class II) was initiated on October 30, 2013. Its most recent 510(k) clearance was granted on February 17, 2012.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 5
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0852-2014 | Class II | The ACUTE Innovations Modular RibLoc System (RibLoc U plus) is comprised titanium plates and screws | October 30, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K120163 | ACUTE INNOVATIONS BIOBRIDGE RESORBABLE PLATING SYSTEM | February 17, 2012 |
| K113318 | ACUTE INNOVATIONS MODULAR RIBLOC SYSTEM | January 12, 2012 |
| K101170 | ACUTE INNOVATIONS STERNAL FIXATION SYSTEM | September 17, 2010 |
| K081588 | RE-ZORB PLATING SYSTEM | September 3, 2008 |
| K061206 | ACUTE BONE SCREW | June 19, 2006 |