Dynasplint Systems, Inc.
Country not established FDA establishment FEI 1121034
- Devices
- 2
- Registrations
- FDA
- FDA recalls
- 0
What Dynasplint Systems, Inc. makes
Dynasplynt Systems, Inc. manufactures external fixation devices and universal dynamic external fixators, which are used for stabilizing and immobilizing fractured bones during the healing process.
Their products are classified as Class I and Class II devices under FDA regulations and are listed in the FDA’s 510(k) clearance registry. The company is based in the United States.
Catalogue
External Fixation Ref K904973
510(k) 510(k)Universal Dynasplint Ref K822767
510(k) 510(k)
Company details
- FDA FEI number
- 1121034
- Address
- 150 LOG CANOE CIRCLE, STEVENSVILLE, MD, 21666
Frequently asked questions
How many devices does DYNASPLINT SYSTEMS, INC. have in the registry?
The registry currently lists 2 devices for DYNASPLINT SYSTEMS, INC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list DYNASPLINT SYSTEMS, INC.'s devices?
Among its 2 most recently registered devices, DYNASPLINT SYSTEMS, INC. has devices listed in FDA 510(k) (2 devices).
What risk classes do DYNASPLINT SYSTEMS, INC.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for DYNASPLINT SYSTEMS, INC.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from DYNASPLINT SYSTEMS, INC. in the registry?
The most recently registered devices listed for DYNASPLINT SYSTEMS, INC. include EXTERNAL FIXATION and UNIVERSAL DYNASPLINT.