Stony Brook Surgical Innovations, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Stony Brook Surgical Innovations, Inc. makes
Stony Brook Surgical Innovations, Inc. manufactures medical devices for sternal closure, including a sternal band and sternal sutures designed to aid in the secure approximation of sternal edges during surgical procedures.
The company’s portfolio is regulated under FDA’s Class II device classification, with products listed via the 510(k) pathway. These devices are based in the United States.
Catalogue
Sternal Band Ref K930015
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Stony Brook Surgical Innovations, Inc. have in the registry?
The registry currently lists 2 devices for Stony Brook Surgical Innovations, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Stony Brook Surgical Innovations, Inc.'s devices?
Among its 2 most recently registered devices, Stony Brook Surgical Innovations, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Stony Brook Surgical Innovations, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Stony Brook Surgical Innovations, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Stony Brook Surgical Innovations, Inc. in the registry?
The most recently registered devices listed for Stony Brook Surgical Innovations, Inc. include STERNAL BAND and STONY BROOK SURGICAL INNOVAIONS STERNA-WIRE (STERNAL SUTURES).