Medicrea
Country not established
- Devices
- 4
What Medicrea makes
Medicrea manufactures spinal fixation systems, including the PASS 2 and PASSMED spinal systems for surgical stabilization, as well as the Osmosys calcium phosphate ceramic bone filler for spinal fusion applications. The company also produces the Impix Manta cervical interbody device for intervertebral support in the cervical spine.
These devices are classified as Class II under FDA regulations and are authorised via the 510(k) pathway. Medicrea’s products are listed in the FDA’s 510(k) registry. The company is based in the United States.
Catalogue
Pass 2 Spinal System Ref K062136
Regimes: 510(k) Registry: 510(k)Passmed Spinal System Ref K032094
Regimes: 510(k) Registry: 510(k)Osmosys Calcium Phosphate Ceramic Bone Filler Ref K050490
Regimes: 510(k) Registry: 510(k)Impix Manta Cervical Interbody Device Ref K100484
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Medicrea have in the registry?
The registry currently lists 4 devices for Medicrea. Devices recorded under merged duplicate company entries are counted once.
Which registries list Medicrea's devices?
Among its 4 most recently registered devices, Medicrea has devices listed in FDA 510(k) (4 devices).
What risk classes do Medicrea's devices fall under?
Among its 4 most recently registered devices, the classes recorded for Medicrea's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Medicrea in the registry?
The most recently registered devices listed for Medicrea include PASS 2 SPINAL SYSTEM, PASSMED SPINAL SYSTEM, OSMOSYS CALCIUM PHOSPHATE CERAMIC BONE FILLER and IMPIX MANTA CERVICAL INTERBODY DEVICE.