Spartek Medical, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Spartek Medical, Inc. makes
Spartek Medical, Inc. manufactures orthopedic spinal fixation systems, including variable-angle pedicle screw devices designed for posterior spinal fusion procedures. These products are intended for use in stabilizing the spine through surgical intervention.
The company’s devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The portfolio is regulated in the United States, where the manufacturer is based.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Spartek Medical, Inc. have in the registry?
The registry currently lists 2 devices for Spartek Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Spartek Medical, Inc.'s devices?
Among its 2 most recently registered devices, Spartek Medical, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Spartek Medical, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Spartek Medical, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Spartek Medical, Inc. in the registry?
The most recently registered devices listed for Spartek Medical, Inc. include SPARTEK VARIABLE ANGLE PEDICLE SCREW POSTERIOR FUSION SYSTEM.