Danek Medical, Inc.
United StatesFDA applicant, unverified
- Devices
- 56
What Danek Medical, Inc. makes
Danek Medical, Inc. manufactures spinal fixation hardware, including modifications of the TSRH and ZPlate-ATL systems, pedicle screw plating (Townley system), spinal rods (Precision Rod Set), and overhead arm slings. Their portfolio also covers diagnostic tools like the SpinalScope, soft goods such as splints and lumbar support devices, and accessories like side rail pads and clavicular straps.
The company’s devices are regulated under FDA 510(k) clearance, spanning Class I and Class II classifications. Products are listed in the FDA’s 510(k) registry, and the manufacturer is based in the United States.
Catalogue
Search and filter all 56 devicesDeviceDevice · Authorizations Verified Status Regime Registry Class
Macular Function Analyzer Ref K843227
Regimes: 510(k) Registry: 510(k)Wheelchair Patient Restraints Ref K823816
Regimes: 510(k) Registry: 510(k)Sofamor Orthopaedic Instruments Ref K933242
Regimes: 510(k) Registry: 510(k)Atlantis Anterior Cervical Plate System Ref K993855
Regimes: 510(k) Registry: 510(k)Danek Irrigating Burr (Dib) Set Ref K890090
Regimes: 510(k) Registry: 510(k)T-Bolt And Nut Ref K911306
Regimes: 510(k) Registry: 510(k)
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