Ceterix Orthopaedics, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Ceterix Orthopaedics, Inc. makes
Ceterix Orthopaedics, Inc. manufactures meniscal repair systems, including the NovoStitch Pro and NovoStitch Plus, designed for surgical fixation of meniscal tears in the knee. These devices are intended for use in arthroscopic procedures, providing suturing solutions for partial and complex meniscal injuries. The portfolio includes variations such as the NovoStitch Pro Meniscal Repair System (CTX-A004, size 0) for specific anatomical applications.
The company’s devices are classified as Class II under FDA regulations, requiring premarket notification (510(k)) clearance. These products are listed in the FDA’s 510(k) database, reflecting their authorised status for commercial distribution in the United States. The manufacturer is based in the US.
Catalogue
NovoStitch Pro Meniscal Repair System Ref K180531
Regimes: 510(k) Registry: 510(k)NovoStitch Plus Meniscal Repair System Ref K143356
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Ceterix Orthopaedics, Inc. have in the registry?
The registry currently lists 3 devices for Ceterix Orthopaedics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ceterix Orthopaedics, Inc.'s devices?
Among its 3 most recently registered devices, Ceterix Orthopaedics, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Ceterix Orthopaedics, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Ceterix Orthopaedics, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Ceterix Orthopaedics, Inc. in the registry?
The most recently registered devices listed for Ceterix Orthopaedics, Inc. include NovoStitch Pro Meniscal Repair System, NovoStitch Plus Meniscal Repair System and NovoStitch Pro Meniscal Repair System, CTX-A004 (size 0).