Acute Innovations, LLC
United StatesFDA applicant, unverified
- Devices
- 39
- FDA recalls
- 2
At a glance
Market reach
- United States
- FDA recalls
What Acute Innovations, LLC makes
Acute Innovations, LLC manufactures orthopedic fixation systems for sternal and rib stabilization, including plating and screw solutions designed for surgical applications. Their portfolio includes resorbable plating systems intended for gradual absorption by the body, as well as modular rib fixation devices for internal stabilization. The company also produces bone screws tailored for specific fixation needs in orthopedic procedures.
All listed devices fall under FDA Class II regulation and have been authorised via the 510(k) pathway. The products are registered with the U.S. Food and Drug Administration under this framework. The company operates from the United States.
Catalogue
Search and filter all 39 devicesCompany details
- DUNS number
- 619225415
- [email protected]
- Phone
- 18666234137
FDA recalls
FDA recall records list 2 recalls initiated by Acute Innovations, LLC, the earliest on 2011-02-28 and the most recent on 2013-10-30. By recorded status: 2 terminated. The reasons filed fall into these groups: mechanical integrity and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2013
- 30 Oct 2013 Z-0852-2014 Class II Terminated The ACUTE Innovations Ribloc U plus Rib Fracture Plating System is recalled because it has the potential to malfunction during installation in a surgery.
2011
- 28 Feb 2011 Z-0336-2012 Unclassified (pre-2012) Terminated RibLoc screw from lot L1008007 was out of specification. It would not engage with the hex tip properly.
Full distribution text
- 28 Feb 2011 Z-0336-2012 Unclassified (pre-2012) Terminated RibLoc screw from lot L1008007 was out of specification. It would not engage with the hex tip properly.
Frequently asked questions
How many devices does Acute Innovations, LLC have in the registry?
The registry currently lists 39 devices for Acute Innovations, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Acute Innovations, LLC's devices?
Among its 39 most recently registered devices, Acute Innovations, LLC has devices listed in FDA 510(k) (5 devices) and FDA GUDID (34 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Acute Innovations, LLC's devices fall under?
Among its 39 most recently registered devices, the classes recorded for Acute Innovations, LLC's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Acute Innovations, LLC?
FDA recall records list 2 recalls initiated by Acute Innovations, LLC, the most recent initiated on 30 Oct 2013. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Acute Innovations, LLC in the registry?
The most recently registered devices listed for Acute Innovations, LLC include RibLoc RBL1401, RibLoc RBP1103, RibLoc RBP1201 and RibLoc RBL1304.