Osteomed Implantes, Ltda
BrazilFDA applicant, unverified
- Devices
- 3
What Osteomed Implantes, Ltda makes
Osteomed Implantes, Ltda manufactures spinal fixation and interbody fusion devices, including pedicular screws, cervical intersomatic spacers (PEEK-based), and anterior cervical plating systems for surgical stabilization of the spine.
These products are classified as Class II devices under FDA regulations and are authorised via the 510(k) pathway. The company operates from the US and has its devices listed in the FDA’s 510(k) registry.
Catalogue
DPZ Pedicular Fixation System Ref K150294
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Anterior Cervical Plate System Ref K151553
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Osteomed Implantes, Ltda have in the registry?
The registry currently lists 3 devices for Osteomed Implantes, Ltda. Devices recorded under merged duplicate company entries are counted once.
Which registries list Osteomed Implantes, Ltda's devices?
Among its 3 most recently registered devices, Osteomed Implantes, Ltda has devices listed in FDA 510(k) (3 devices).
What risk classes do Osteomed Implantes, Ltda's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Osteomed Implantes, Ltda's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Osteomed Implantes, Ltda in the registry?
The most recently registered devices listed for Osteomed Implantes, Ltda include DPZ Pedicular Fixation System, Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral Space Maintenance Device - DIMEI PEEK, Intersomatic Transforaminal - TLIF PEEK and Anterior Cervical Plate System.