Specs USA, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Specs USA, Inc. makes
Specs USA, Inc. manufactures the STENODOC, a device used for endoscopic visualization and documentation, and the ESKA MODULAR HIP SYSTEM, a modular implant for hip arthroplasty procedures.
The company’s products are classified as Class II devices under FDA regulations and are supported by 510(k) clearances. The manufacturer is based in the United States.
Catalogue
Stenodoc Ref K946349
Regimes: 510(k) Registry: 510(k)Eska Modular Hip System Ref K993027
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Specs USA, Inc. have in the registry?
The registry currently lists 2 devices for Specs USA, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Specs USA, Inc.'s devices?
Among its 2 most recently registered devices, Specs USA, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Specs USA, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Specs USA, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Specs USA, Inc. in the registry?
The most recently registered devices listed for Specs USA, Inc. include STENODOC and ESKA MODULAR HIP SYSTEM.