Ortho Tec, LLC
United StatesFDA applicant, unverified
- Devices
- 23
What Ortho Tec, LLC makes
Ortho Tec, LLC manufactures spinal orthopedic devices including cervical plates, spinal systems with various connectors, spinal screws, plate systems, and calcium phosphate ceramic products. Their specific products consist of ORIA Cervical Plates, ORIA Spinal System with Domino and Tube Connectors, SCS Claris Spinal Screws, ORIA Spinal Clip System with various connectors, Zenith Plate System, Claris Plate System, and EOVIA Calcium Phosphate Ceramic.
Ortho Tec, LLC is based in the US and their devices are classified as Class II, listed in the FDA 510(k) registry. The company's portfolio includes various spinal instrumentation systems and orthopedic implants that meet these regulatory requirements.
Catalogue
Search and filter all 23 devicesFrequently asked questions
How many devices does Ortho Tec, LLC have in the registry?
The registry currently lists 23 devices for Ortho Tec, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ortho Tec, LLC's devices?
Among its 23 most recently registered devices, Ortho Tec, LLC has devices listed in FDA 510(k) (23 devices).
What risk classes do Ortho Tec, LLC's devices fall under?
Among its 23 most recently registered devices, the classes recorded for Ortho Tec, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Ortho Tec, LLC in the registry?
The most recently registered devices listed for Ortho Tec, LLC include ORIA CERVICAL PLATES, ORIA SPINAL SYSTEM, DOMINO AND TUBE CONNECTORS, SCS CLARIS SPINAL SCREWS, TYPES V, G, E and ORIA SPINAL CLIP SYSTEM EXTENDED OMNIAXIAL CONNECTORS (CO05 & CO07).