Danek Group, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Danek Group, Inc. makes
Danek Group, Inc. manufactures orthopedic fixation systems, including the DYNA-LOK ANTERIOR PLATING SYSTEM for spinal stabilization and the GDLH VARIABLE ANGLE CONNECTOR for modular spinal hardware, designed for surgical use in spinal fusion procedures.
These devices are classified as Class II under FDA regulations and are supported by 510(k) clearance records. The company is based in the United States.
Catalogue
Dyna-Lok Anterior Plating System Ref K936307
Regimes: 510(k) Registry: 510(k)Gdlh Variable Angle Connector Ref K934582
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Danek Group, Inc. have in the registry?
The registry currently lists 2 devices for Danek Group, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Danek Group, Inc.'s devices?
Among its 2 most recently registered devices, Danek Group, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Danek Group, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Danek Group, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Danek Group, Inc. in the registry?
The most recently registered devices listed for Danek Group, Inc. include DYNA-LOK ANTERIOR PLATING SYSTEM and GDLH VARIABLE ANGLE CONNECTOR.