Metronic, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
What Metronic, Inc. makes
Metronic, Inc. manufactures orthopedic surgical instruments, including the ORTHOFLEX™ line for spinal and orthopedic procedures, as well as electrophysiology leads like the MYOCARDIAL UNIPOLAR LEAD (Model 4951M). The company also produces imaging systems, such as the IMAGE PROCESSING SYS A3, and specialized medical devices like the MODEL 5866-9M and MODEL 6981M for procedural applications.
The company’s devices are classified under FDA categories Class I, Class II, and Class III, with submissions recorded in the FDA’s 510(k) registry. These products are intended for use in the United States, where regulatory compliance aligns with U.S. medical device requirements.
Catalogue
Medtronic(R) Orthoflex(Tm) Ref K874884
Regimes: 510(k) Registry: 510(k)Model 5866-9M & Model 6981M Ref K911827
Regimes: 510(k) Registry: 510(k)Image Processing Sys A3 Ref K832505
Regimes: 510(k) Registry: 510(k)Model 4951M Myocardial Unipolar Lead Ref K031210
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Metronic, Inc. have in the registry?
The registry currently lists 4 devices for Metronic, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Metronic, Inc.'s devices?
Among its 4 most recently registered devices, Metronic, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Metronic, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Metronic, Inc.'s devices are Class I, Class II and Class III. Each device page shows its own class and authorisation.
What are the newest devices from Metronic, Inc. in the registry?
The most recently registered devices listed for Metronic, Inc. include MEDTRONIC(R) ORTHOFLEX(TM), MODEL 5866-9M & MODEL 6981M, IMAGE PROCESSING SYS A3 and MODEL 4951M MYOCARDIAL UNIPOLAR LEAD.