Phygen, LLC
United StatesFDA applicant, unverified
- Devices
- 7
What Phygen, LLC makes
Phygen, LLC manufactures pedicle screw systems for spinal fixation, including monoaxial and multi-axial designs such as the DEL MAR, LEUCADIA, and LAGUNA series. These devices are intended for use in orthopedic and spinal surgical procedures to stabilize vertebrae, with variations for minimally invasive surgery (MIS). The portfolio includes both manual and auto-locking screw mechanisms for enhanced fixation.
The company’s pedicle screw systems 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, reflecting their regulatory authorization for commercial distribution in the United States.
Catalogue
Del Mar Monoaxial Pedicle Screw System Ref K110679
Regimes: 510(k) Registry: 510(k)Leucadia 4.5 Mm Pedicle Screw System Ref K120355
Regimes: 510(k) Registry: 510(k)Laguna Pedicle Screw System Ref K103748
Regimes: 510(k) Registry: 510(k)Leucadia Pedicle Screw System Ref K103102
Regimes: 510(k) Registry: 510(k)Leucadia Autolok Pedicle Screw System Ref K113366
Regimes: 510(k) Registry: 510(k)Leucadia Pedicle Screw System Ref K110588
Regimes: 510(k) Registry: 510(k)Leucadia(Tm) Mis Pedicle Screw System Ref K112931
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Phygen, LLC have in the registry?
The registry currently lists 7 devices for Phygen, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Phygen, LLC's devices?
Among its 7 most recently registered devices, Phygen, LLC has devices listed in FDA 510(k) (7 devices).
What risk classes do Phygen, LLC's devices fall under?
Among its 7 most recently registered devices, the classes recorded for Phygen, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Phygen, LLC in the registry?
The most recently registered devices listed for Phygen, LLC include DEL MAR MONOAXIAL PEDICLE SCREW SYSTEM, LEUCADIA 4.5 MM PEDICLE SCREW SYSTEM, LAGUNA PEDICLE SCREW SYSTEM and LEUCADIA PEDICLE SCREW SYSTEM.