Acute Innovations, LLC
Hillsboro, OR, US
Acute Innovations, LLC appears in FDA device records in Hillsboro, OR. FDA records list 5 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 2 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 5 510(k) clearances for Acute Innovations, LLC between 2006 and 2012. The busiest year on record is 2012, with 2. The most recent is 2012, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2006 | 1 |
| 2008 | 1 |
| 2010 | 1 |
| 2012 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K120163 | ACUTE INNOVATIONS BIOBRIDGE RESORBABLE PLATING SYSTEM | HRS | Substantially Equivalent | |
| K113318 | ACUTE INNOVATIONS MODULAR RIBLOC SYSTEM | HRS | Substantially Equivalent | |
| K101170 | ACUTE INNOVATIONS STERNAL FIXATION SYSTEM | KTT | Substantially Equivalent | |
| K081588 | RE-ZORB PLATING SYSTEM | HRS | Substantially Equivalent | |
| K061206 | ACUTE BONE SCREW | HWC | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0852-2014 | The ACUTE Innovations Modular RibLoc System (RibLoc U plus) is comprised titanium plates and screws that are used to stabilize rib fractures, fusions and osteotomies during the normal bone healing process. The plates are manufactured from titanium and the screws are manufactured from titanium alloy. Surgical instrumentation is supplied with the implants in a surgical tray to facilitate the proper insertion of the plates and screws. The ACUTE Innovations Modular RibLoc System is intended to stabilize and provide fixation for fractures, fusions, and osteotomies of the ribs, and for reconstructions of the chest wall and sternum. Part Numbers: RBL1301- 50 mm Rib Plate; RBL1302- 75 mm Rib Plate; RBL1303- 115 mm Rib Plate; RBL1304- 155 mm Rib Plate; RBL1305- 215 mm Rib Plate; | The ACUTE Innovations Ribloc U plus Rib Fracture Plating System is recalled because it has the potential to malfunction during installation in a surgery. | Class II | Terminated | |
| Z-0336-2012 | 10mm x 2.7mm RibLoc Screw, a component of the RibLoc Rib Fracture Plating System, Model RBP1202. The product is labeled in parts: "***Ribloc Rib Fracture Plating System***MATERIAL: Titanium***Rx ONLY***NON STERILE***SCREW***ACUTE Innovations LLC 21421 NW Jacobson Road, Suite 700 Hillsboro, OR 97124 USA www.acuteinnovations.com*** MediMark Europe Sarl*** 11 rue Emile ZOLA BP 2332****38003 GRENOBLE CEDEX 2 FRANCE" The Acumed Rib Congruent Bone Plate System is indicated for use in providing fixation during fractures, fusions, and osteotomies for the rib. The Acumed Rib Congruent Bone Plate System includes plates and screws designed specifically for the rib. | RibLoc screw from lot L1008007 was out of specification. It would not engage with the hex tip properly. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain