Surgtech, Inc.
United StatesFDA applicant, unverified FDA FEI 3011170410
- Devices
- 6
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Surgtech, Inc. makes
Surgtech, Inc. manufactures orthopedic implants and fixation systems, including total hip and knee arthroplasty components, bipolar hip heads, spinal fixation hardware for thoracolumbosacral procedures, interbody cages, and trauma-related orthopedic devices.
The company’s portfolio is regulated under FDA Class II devices, with products authorised via the 510(k) pathway. These devices are listed in the FDA’s 510(k) clearance registry, and the manufacturer is based in the United States.
Catalogue
MALUC™ Total Hip Arthroplasty System Ref K162125
Regimes: 510(k) Registry: 510(k)SurgTech GENOLL Total Knee System Ref K191192
Regimes: 510(k) Registry: 510(k)SurgTech Bipolar Head System Ref K173455
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
SurgTech Interbody System Ref K152200
Regimes: 510(k) Registry: 510(k)SurgTech Trauma System Ref K161894
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3011170410
- Address
- 24600 Center Ridge Road, Suite 195, Westlake, OH, 44145
Frequently asked questions
How many devices does Surgtech, Inc. have in the registry?
The registry currently lists 6 devices for Surgtech, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Surgtech, Inc.'s devices?
Among its 6 most recently registered devices, Surgtech, Inc. has devices listed in FDA 510(k) (6 devices).
What risk classes do Surgtech, Inc.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Surgtech, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Surgtech, Inc. in the registry?
The most recently registered devices listed for Surgtech, Inc. include MALUC™ Total Hip Arthroplasty System, SurgTech GENOLL Total Knee System, SurgTech Bipolar Head System and SurgTech Thoracolumbosacral (TLS) Posterior Fixation System.