Arcan Orthopaedic Corp.
United StatesFDA applicant, unverified
- Devices
- 5
What Arcan Orthopaedic Corp. makes
Arcan Orthopaedic Corp. manufactures posterior spinal fixation systems, including the BRYAN Posterior Spinal Fixator (BPSF) and its modified variants, as well as the BRYAN Spinal Fixator (BSF). These devices are designed for internal spinal stabilization, aiding in the surgical treatment of spinal deformities or injuries.
The company’s products are classified as Class II medical devices under FDA regulations and are supported by 510(k) clearances. The portfolio is listed in the FDA’s 510(k) database, reflecting their regulatory status in the United States.
Catalogue
Bryan Posterior Spinal Fixator (Bpsf), Modified Ref K971457
Regimes: 510(k) Registry: 510(k)Bryan Posterior Spinal Fixator (Bpsf) Ref K953416
Regimes: 510(k) Registry: 510(k)Bryan Posterior Spinal Fixator (Bpsf) Ref K945435
Regimes: 510(k) Registry: 510(k)Bryan Spinal Fixater (Bsf) Ref K914548
Regimes: 510(k) Registry: 510(k)Bryan Posterior Spinal Fixator (Modification) Ref K955927
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Arcan Orthopaedic Corp. have in the registry?
The registry currently lists 5 devices for Arcan Orthopaedic Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Arcan Orthopaedic Corp.'s devices?
Among its 5 most recently registered devices, Arcan Orthopaedic Corp. has devices listed in FDA 510(k) (5 devices).
What risk classes do Arcan Orthopaedic Corp.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Arcan Orthopaedic Corp.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Arcan Orthopaedic Corp. in the registry?
The most recently registered devices listed for Arcan Orthopaedic Corp. include BRYAN POSTERIOR SPINAL FIXATOR (BPSF), MODIFIED, BRYAN POSTERIOR SPINAL FIXATOR (BPSF), BRYAN SPINAL FIXATER (BSF) and BRYAN POSTERIOR SPINAL FIXATOR (MODIFICATION).