Pisharodi Surgicals, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
What Pisharodi Surgicals, Inc. makes
Pisharodi Surgicals, Inc. manufactures spinal fixation devices, including cervical plates and pedicle screw systems for surgical stabilization of the spine. The portfolio includes the Simplex Cervical Fixation System, Radix Cervical Plate, and modifications to the Universal Multiaxis (UniMax) Pedicle Screw System, designed for precise alignment and bone fixation.
These devices are classified as Class II under FDA regulations and are supported by 510(k) clearances. The company’s products are listed in the FDA’s 510(k) database, adhering to U.S. medical device compliance standards.
Catalogue
Simplex Cervical Fixation System Ref K070335
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Radix Cervical Plate Ref K033951
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Pisharodi Surgicals, Inc. have in the registry?
The registry currently lists 4 devices for Pisharodi Surgicals, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Pisharodi Surgicals, Inc.'s devices?
Among its 4 most recently registered devices, Pisharodi Surgicals, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Pisharodi Surgicals, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Pisharodi Surgicals, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Pisharodi Surgicals, Inc. in the registry?
The most recently registered devices listed for Pisharodi Surgicals, Inc. include SIMPLEX CERVICAL FIXATION SYSTEM, MODIFICATION TO UNIVERSAL MULTIAXIS (UNIMAX) PEDICLE SCREW SYSTEM, RADIX CERVICAL PLATE and UNIVERSAL MULTIAXIS (UNIMAX) PEDICLE SCREW SYSTEM.