Epitek, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Epitek, Inc. makes
Epitek, Inc. manufactures orthopedic anchorage devices, including anchorage closure devices, a scope model (000003), and anchorage access kits designed for surgical applications in bone fixation procedures.
The company’s products are regulated as Class II devices under FDA 510(k) clearance requirements and are listed in the FDA’s 510(k) database. Epitek, Inc. is based in the United States.
Catalogue
Anchorage Closure Device Ref K073096
Regimes: 510(k) Registry: 510(k)Anchorage Scope, Model 000003 Ref K080780
Regimes: 510(k) Registry: 510(k)Anchorage Access Kit Ref K073507
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Epitek, Inc. have in the registry?
The registry currently lists 3 devices for Epitek, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Epitek, Inc.'s devices?
Among its 3 most recently registered devices, Epitek, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Epitek, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Epitek, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Epitek, Inc. in the registry?
The most recently registered devices listed for Epitek, Inc. include ANCHORAGE CLOSURE DEVICE, ANCHORAGE SCOPE, MODEL 000003 and ANCHORAGE ACCESS KIT.