Changzhou Dean Medical Instrument Co, Ltd.
ChinaFDA applicant, unverified
- Devices
- 2
What Changzhou Dean Medical Instrument Co, Ltd. makes
Changzhou Dean Medical Instrument Co, Ltd. manufactures spinal surgical implants, including locking compression bone plates and screw systems designed for spinal stabilization. Their product line also includes general spinal fixation systems for orthopedic procedures.
These devices are classified as Class II under regulatory frameworks and are listed in the FDA’s 510(k) registry. The company operates with a presence in the United States, adhering to applicable medical device regulations.
Catalogue
General Spinal System Ref K134011
Regimes: 510(k) Registry: 510(k)Locking Compression Bone Plates And Screw System Ref K133525
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Changzhou Dean Medical Instrument Co, Ltd. have in the registry?
The registry currently lists 2 devices for Changzhou Dean Medical Instrument Co, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Changzhou Dean Medical Instrument Co, Ltd.'s devices?
Among its 2 most recently registered devices, Changzhou Dean Medical Instrument Co, Ltd. has devices listed in FDA 510(k) (2 devices).
What risk classes do Changzhou Dean Medical Instrument Co, Ltd.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Changzhou Dean Medical Instrument Co, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Changzhou Dean Medical Instrument Co, Ltd. in the registry?
The most recently registered devices listed for Changzhou Dean Medical Instrument Co, Ltd. include GENERAL SPINAL SYSTEM and LOCKING COMPRESSION BONE PLATES AND SCREW SYSTEM.