Philadelphia Medical Specialties
Country not established
- Devices
- 6
What Philadelphia Medical Specialties makes
Philadelphia Medical Specialties manufactures intracranial pressure (ICP) monitoring devices, including the Philly Bolt and its variants for adult and infant use. These products are designed for surgical procedures to secure ICP monitoring sensors in place, with accompanying procedure kits for clinical application.
The company’s ICP monitoring devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. These products are registered in the U.S. and comply with applicable medical device standards for intracranial pressure measurement and fixation.
Catalogue
Philly Bolt Ref K813440
Regimes: 510(k) Registry: 510(k)Class Ii Device For I.C.P. Monitoring Ref K822636
Regimes: 510(k) Registry: 510(k)Philly Bolt Adult Procedure Kit Ref K823459
Regimes: 510(k) Registry: 510(k)Philly Bolts Ref K834148
Regimes: 510(k) Registry: 510(k)Philly Infant Bolt Ref K840999
Regimes: 510(k) Registry: 510(k)Philly Infant Bolt Ref K820151
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Philadelphia Medical Specialties have in the registry?
The registry currently lists 6 devices for Philadelphia Medical Specialties. Devices recorded under merged duplicate company entries are counted once.
Which registries list Philadelphia Medical Specialties's devices?
Among its 6 most recently registered devices, Philadelphia Medical Specialties has devices listed in FDA 510(k) (6 devices).
What risk classes do Philadelphia Medical Specialties's devices fall under?
Among its 6 most recently registered devices, the classes recorded for Philadelphia Medical Specialties's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Philadelphia Medical Specialties in the registry?
The most recently registered devices listed for Philadelphia Medical Specialties include PHILLY BOLT, CLASS II DEVICE FOR I.C.P. MONITORING, PHILLY BOLT ADULT PROCEDURE KIT and PHILLY BOLTS.