Spirox, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Spirox, Inc. makes
Spirox, Inc. manufactures absorbable nasal implants, including the INEX and Latera models, designed for internal sinus procedures. These devices are intended for temporary structural support during sinus surgery and are intended to be resorbed by the body over time. The portfolio also includes the SPIROX INEX DEVICE, a variant for specific sinus applications.
The company’s products are classified as Class II medical devices under FDA regulations and are supported by 510(k) clearances. These devices are listed in the FDA’s 510(k) database. Spirox, Inc. is headquartered in the United States.
Catalogue
INEX Absorbable Nasal Implant Ref K152958
Regimes: 510(k) Registry: 510(k)Latera Absorbable Nasal Implant Ref K161191
Regimes: 510(k) Registry: 510(k)Spirox Inex Device Ref K132920
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Spirox, Inc. have in the registry?
The registry currently lists 3 devices for Spirox, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Spirox, Inc.'s devices?
Among its 3 most recently registered devices, Spirox, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Spirox, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Spirox, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Spirox, Inc. in the registry?
The most recently registered devices listed for Spirox, Inc. include INEX Absorbable Nasal Implant, Latera Absorbable Nasal Implant and SPIROX INEX DEVICE.