Oak Tree Engineering, LLC
United StatesFDA applicant, unverified
- Devices
- 2
What Oak Tree Engineering, LLC makes
Oak Tree Engineering, LLC manufactures spinal fixation systems, including the Fixxsure Anterior Lumbar Plate and Screw System and the OAKTREE Anterior Lumbar Plate and Screw System. These devices are designed for internal fixation of the lumbar spine, providing stability during the healing process of degenerative or traumatic spinal conditions.
The company’s products are classified as Class II devices under FDA regulations and are listed via the 510(k) pathway. The portfolio is authorised for use in the United States, where the manufacturer is based.
Catalogue
Fixxsure Anterior Lumbar Plate and Screw System Ref K211932
Regimes: 510(k) Registry: 510(k)OAKTREE Anterior Lumbar Plate and Screw System Ref K220843
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Oak Tree Engineering, LLC have in the registry?
The registry currently lists 2 devices for Oak Tree Engineering, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Oak Tree Engineering, LLC's devices?
Among its 2 most recently registered devices, Oak Tree Engineering, LLC has devices listed in FDA 510(k) (2 devices).
What risk classes do Oak Tree Engineering, LLC's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Oak Tree Engineering, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Oak Tree Engineering, LLC in the registry?
The most recently registered devices listed for Oak Tree Engineering, LLC include Fixxsure Anterior Lumbar Plate and Screw System and OAKTREE Anterior Lumbar Plate and Screw System.