Esm Technologies, LLC
United StatesFDA applicant, unverified
- Devices
- 2
What Esm Technologies, LLC makes
Esm Technologies, LLC manufactures internal fixation devices, including the Translation Plate Phase 1 (T-1 Plate) and Phase 2 (T-2 Plate), designed for orthopedic surgical applications. These plates are used in bone stabilization procedures, particularly for fractures requiring controlled bone alignment and healing.
The company’s products are classified as Class II medical devices under FDA regulations and are listed via the 510(k) clearance pathway. These devices are intended for use within the United States, adhering to applicable regulatory standards for orthopedic hardware.
Catalogue
T-Plate Anterior Fixation System Ref K051764
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Esm Technologies, LLC have in the registry?
The registry currently lists 2 devices for Esm Technologies, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Esm Technologies, LLC's devices?
Among its 2 most recently registered devices, Esm Technologies, LLC has devices listed in FDA 510(k) (2 devices).
What risk classes do Esm Technologies, LLC's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Esm Technologies, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Esm Technologies, LLC in the registry?
The most recently registered devices listed for Esm Technologies, LLC include T-PLATE ANTERIOR FIXATION SYSTEM and THE TRANSLATION PLATE PHASE 1 (T-1 PLATE) AND PHASE 2 (T-2 PLATE).