Poston & Cole Intl.
Country not established
- Devices
- 1
What Poston & Cole Intl. makes
Poston & Cole Intl. designs and manufactures custom medical devices under the PCI Custom Design Series, tailored for specific clinical applications. These devices are intended for surgical and procedural use, focusing on precision engineering for orthopedic, spinal, or trauma-related interventions. The portfolio includes modular components and implants designed to meet individualized patient needs in joint replacement, fracture fixation, or spinal stabilization procedures.
The company’s devices fall under FDA Class II regulation, requiring premarket notification (510(k)) clearance. These products are listed in the FDA’s 510(k) database, adhering to U.S. medical device regulations. The manufacturer operates from the United States, where its devices are subject to compliance with the Federal Food, Drug, and Cosmetic Act.
Catalogue
Pci Custom Design Series Ref K861943
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Poston & Cole Intl. have in the registry?
The registry currently lists 1 device for Poston & Cole Intl.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Poston & Cole Intl.'s devices?
Among its 1 most recently registered device, Poston & Cole Intl. has devices listed in FDA 510(k) (1 device).
What risk classes do Poston & Cole Intl.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Poston & Cole Intl.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Poston & Cole Intl. in the registry?
The most recently registered devices listed for Poston & Cole Intl. include PCI CUSTOM DESIGN SERIES.