Nuvasive Specialized Orthopedics, Incorporated
United StatesFDA applicant, unverified
- Devices
- 4
What Nuvasive Specialized Orthopedics, Incorporated makes
Nuvasive Specialized Orthopedics manufactures spinal fixation and distraction systems, including the MAGEC® System for adjustable growth modulation and the Precice Max System for internal lengthening of long bones. Their portfolio also includes supplemental surgical instrument trays designed for spinal procedures.
These devices are classified as Class II under FDA regulations and are authorised via the 510(k) clearance process. The company is based in the United States.
Catalogue
MAGEC® System Ref K171791
Regimes: 510(k) Registry: 510(k)Supplemental Instrument Trays Ref K170939
Regimes: 510(k) Registry: 510(k)MAGEC Spinal Bracing and Distraction System Ref K233593
Regimes: 510(k) Registry: 510(k)Precice Max System Ref K232267
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Nuvasive Specialized Orthopedics, Incorporated have in the registry?
The registry currently lists 4 devices for Nuvasive Specialized Orthopedics, Incorporated. Devices recorded under merged duplicate company entries are counted once.
Which registries list Nuvasive Specialized Orthopedics, Incorporated's devices?
Among its 4 most recently registered devices, Nuvasive Specialized Orthopedics, Incorporated has devices listed in FDA 510(k) (4 devices).
What risk classes do Nuvasive Specialized Orthopedics, Incorporated's devices fall under?
Among its 4 most recently registered devices, the classes recorded for Nuvasive Specialized Orthopedics, Incorporated's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Nuvasive Specialized Orthopedics, Incorporated in the registry?
The most recently registered devices listed for Nuvasive Specialized Orthopedics, Incorporated include MAGEC® System, Supplemental Instrument Trays, MAGEC Spinal Bracing and Distraction System and Precice Max System.