Baxano, Inc.
United StatesFDA applicant, unverified
- Devices
- 10
What Baxano, Inc. makes
Baxano, Inc. manufactures surgical instruments and devices for spinal and neural procedures, including ultra-low-profile rongeurs for precise bone removal, IO-Flex catheters for intraoperative imaging guidance, and neural localization probes for targeting nerve pathways. The company also produces microblade shavers and accessories for tissue resection, as well as IO-Tome devices for bone cutting. Additional offerings include neural check devices paired with IO-Flex wires for intraoperative verification of electrode placement.
The company’s portfolio consists of Class II medical devices, all of which are authorised via the FDA’s 510(k) clearance process. These devices are listed under the FDA’s regulatory framework and are intended for use in the United States.
Catalogue
Baxano Ultra Low Profile Rongeur Ref K080494
Regimes: 510(k) Registry: 510(k)Io-Flex Catheter Ref K102594
Regimes: 510(k) Registry: 510(k)Baxano Neural Localization Probe 1.75 And 1.25 Ref K081742
Regimes: 510(k) Registry: 510(k)Ultra Low Profile Rongeur Ref K062711
Regimes: 510(k) Registry: 510(k)Microblade Shaver And Accessories Ref K063231
Regimes: 510(k) Registry: 510(k)Neuro Check Device With Io-Flex Wire Ref K110696
Regimes: 510(k) Registry: 510(k)Neuro Check Device With Io-Flex Wire Ref K113533
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Baxano Neuro Check Device Ref K092729
Regimes: 510(k) Registry: 510(k)Io-Tome Device Ref K113073
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Baxano, Inc. have in the registry?
The registry currently lists 10 devices for Baxano, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Baxano, Inc.'s devices?
Among its 10 most recently registered devices, Baxano, Inc. has devices listed in FDA 510(k) (10 devices).
What risk classes do Baxano, Inc.'s devices fall under?
Among its 10 most recently registered devices, the classes recorded for Baxano, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Baxano, Inc. in the registry?
The most recently registered devices listed for Baxano, Inc. include BAXANO ULTRA LOW PROFILE RONGEUR, IO-FLEX CATHETER, BAXANO NEURAL LOCALIZATION PROBE 1.75 AND 1.25 and ULTRA LOW PROFILE RONGEUR.