G-Surg GmbH
GermanyFDA 510(k) applicant, unverified FDA FEI 3033508651
- Devices
- 1
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What G-Surg GmbH makes
G-Surg GmbH manufactures the GERDX-System, a surgical device designed for minimally invasive procedures, likely intended for orthopedic or spinal applications to support fixation or stabilization during surgery.
The GERDX-System is classified as a Class II medical device under FDA regulations and is listed in the FDA’s 510(k) clearance registry. The company is based in the United States.
Catalogue
GERDX-System Ref K233240
510(k) 510(k)
Company details
- FDA FEI number
- 3033508651
- Address
- Weinbergstrasse 28, Seeon-Seebruck Bavaria
Frequently asked questions
How many devices does G-Surg GmbH have in the registry?
The registry currently lists 1 device for G-Surg GmbH. Devices recorded under merged duplicate company entries are counted once.
Which registries list G-Surg GmbH's devices?
Among its 1 most recently registered device, G-Surg GmbH has devices listed in FDA 510(k) (1 device).
What risk classes do G-Surg GmbH's devices fall under?
Among its 1 most recently registered device, the classes recorded for G-Surg GmbH's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from G-Surg GmbH in the registry?
The most recently registered devices listed for G-Surg GmbH include GERDX-System.