Westcon Orthopedics, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
What Westcon Orthopedics, Inc. makes
Westcon Orthopedics, Inc. manufactures orthopedic fixation components, including sterile and non-sterile wire caps (e.g., K-CAP-E and K-CAP-I) and orthopedic wires and pins (e.g., K-CAPE). These devices are designed for internal fixation in bone surgery, providing secure attachment points for surgical wires or pins. The portfolio also includes orthopedic fixation wire caps intended for use in fracture stabilization procedures.
The company’s devices fall under Class II regulatory classification in the US, requiring premarket notification (510(k)) clearance through the FDA. These products are listed under the 510(k) pathway, adhering to US medical device regulations. The manufacturer operates from the United States.
Catalogue
K-Cap-E, Sterile Ref K914812
Regimes: 510(k) Registry: 510(k)K-Cap-I Orthopedic Fixation Wire Cap Ref K902053
Regimes: 510(k) Registry: 510(k)K-Cap-I, Sterile Ref K912762
Regimes: 510(k) Registry: 510(k)K-Cape Orthopedic Wires And Pins Ref K901525
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Westcon Orthopedics, Inc. have in the registry?
The registry currently lists 4 devices for Westcon Orthopedics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Westcon Orthopedics, Inc.'s devices?
Among its 4 most recently registered devices, Westcon Orthopedics, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Westcon Orthopedics, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Westcon Orthopedics, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Westcon Orthopedics, Inc. in the registry?
The most recently registered devices listed for Westcon Orthopedics, Inc. include K-CAP-E, STERILE, K-CAP-I ORTHOPEDIC FIXATION WIRE CAP, K-CAP-I, STERILE and K-CAPE ORTHOPEDIC WIRES AND PINS.