Response Ortho Solutions, LLC
United StatesFDA applicant, unverified FDA FEI 3045159437
- Devices
- 3
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Response Ortho Solutions, LLC makes
Response Ortho Solutions, LLC manufactures orthopedic external fixation systems, including the Response Ortho Metaphyseal Hinge Fixator System and the Response Ortho Smart Fixator – Hexapod System. These devices are designed for stabilizing and correcting complex bone deformities and fractures, particularly in metaphyseal regions. The Hexapod System incorporates adjustable struts for precise three-dimensional alignment adjustments.
The company’s products are classified as Class II medical devices under FDA regulations and are supported by 510(k) clearance records. The devices are listed in the FDA’s 510(k) database. The manufacturer is based in the United States.
Catalogue
Response Ortho Smart Fixator - Hexapod System Ref K263083
Regimes: 510(k) Registry: 510(k)Response Ortho Metaphyseal Hinge Fixator System Ref K241769
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3045159437
- Address
- 1875 W Woolbright Rd, Boynton Beach, FL, 33426
Frequently asked questions
How many devices does Response Ortho Solutions, LLC have in the registry?
The registry currently lists 3 devices for Response Ortho Solutions, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Response Ortho Solutions, LLC's devices?
Among its 3 most recently registered devices, Response Ortho Solutions, LLC has devices listed in FDA 510(k) (3 devices).
What risk classes do Response Ortho Solutions, LLC's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Response Ortho Solutions, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Response Ortho Solutions, LLC in the registry?
The most recently registered devices listed for Response Ortho Solutions, LLC include Response Ortho Smart Fixator - Hexapod System, Response Ortho Metaphyseal Hinge Fixator System and The Response Ortho Smart Fixator - Hexapod System.