Cert Health Sciences, LLC
United StatesFDA applicant, unverified
- Devices
- 2
What Cert Health Sciences, LLC makes
Cert Health Sciences, LLC manufactures spinal surgical instruments, including the SPINEMED line and its variants (S200B, S200C), designed for orthopedic and spinal procedures.
These devices are classified as Class II under FDA regulations and are authorised via the 510(k) pathway. The company is based in the United States.
Catalogue
Spinemed Ref K030060
Regimes: 510(k) Registry: 510(k)Spinemed S200B/S200C Ref K051013
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Cert Health Sciences, LLC have in the registry?
The registry currently lists 2 devices for Cert Health Sciences, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cert Health Sciences, LLC's devices?
Among its 2 most recently registered devices, Cert Health Sciences, LLC has devices listed in FDA 510(k) (2 devices).
What risk classes do Cert Health Sciences, LLC's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Cert Health Sciences, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Cert Health Sciences, LLC in the registry?
The most recently registered devices listed for Cert Health Sciences, LLC include SPINEMED and SPINEMED S200B/S200C.