Truemed Group, LLC
United StatesFDA 510(k) applicant, unverified
- Devices
- 8
What Truemed Group, LLC makes
Truemed Group, LLC manufactures orthopaedic fixation devices, including non-bioabsorbable, non-sterile bone screws and fixation plates designed for bone stabilization. Their portfolio includes systems for hand, foot, ankle, distal radius, ulna, humerus, tibia, and femur applications, such as the Arzzt 3.5/4.5 Fragment System and the TRUEMED Hand, Foot, and Ankle Plates System.
These devices are classified as Class II under FDA regulations and are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) databases. The company operates from the United States, adhering to applicable regulatory requirements for orthopaedic hardware.
Catalogue
- GUDID
- GUDID
- GUDID
Arzzt 3.5 / 4.5 Small & Large Fragments System Ref K162507
510(k) 510(k)Truemed Hand, Foot And Ankle Plates System Ref K200575
510(k) 510(k)- 510(k) 510(k)
Ins Hilden Tibial Arzzt Ref K133166
510(k) 510(k)Arzzt Distal Radius and Ulna System Ref K182650
510(k) 510(k)
Company details
- DUNS number
- 004154534
Frequently asked questions
How many devices does Truemed Group, LLC have in the registry?
The registry currently lists 8 devices for Truemed Group, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Truemed Group, LLC's devices?
Among its 8 most recently registered devices, Truemed Group, LLC has devices listed in FDA 510(k) (5 devices) and FDA GUDID (3 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Truemed Group, LLC's devices fall under?
Among its 8 most recently registered devices, the classes recorded for Truemed Group, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Truemed Group, LLC in the registry?
The most recently registered devices listed for Truemed Group, LLC include ARZZT 03134101, ARZZT 02095406, ARZZT 02095401 and Arzzt 3.5 / 4.5 Small & Large Fragments System.