Spantron, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Spantron, Inc. makes
Spantron, Inc. manufactures orthopedic fixation devices, including the Spantron Frame Freeze and its modified version, designed for spinal stabilization and internal fixation in surgical procedures.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
The Spantron Frame Freeze Ref K890477
Regimes: 510(k) Registry: 510(k)Modified Spantron Frame Freeze Ref K895546
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Spantron, Inc. have in the registry?
The registry currently lists 2 devices for Spantron, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Spantron, Inc.'s devices?
Among its 2 most recently registered devices, Spantron, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Spantron, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Spantron, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Spantron, Inc. in the registry?
The most recently registered devices listed for Spantron, Inc. include THE SPANTRON FRAME FREEZE and MODIFIED SPANTRON FRAME FREEZE.