Arthrotek, Inc.
United StatesFDA applicant, unverified
- Devices
- 17
What Arthrotek, Inc. makes
Arthrotek, Inc. manufactures orthopedic fixation devices, including resorbable and non-resorbable suture anchors (such as the AllThread, EZLoc, and Hitch Lactosorb variants), screws (including 2.8mm and 3.5mm Lactoscrew anchors and resorbable interference screws), and ACL crosspins. The company also produces diagnostic tools like the Innervue scope system and measurement devices such as the Arthrophonometer, alongside specialized fixation hardware like the Arthrotek Lactonail and Centraloc tibial screw system.
The company’s products are classified under FDA regulations as Class I and Class II devices, with most requiring 510(k) clearance. These devices are listed in the FDA’s 510(k) premarket notification database. Arthrotek, Inc. is based in the United States.
Catalogue
Search and filter all 17 devicesFrequently asked questions
How many devices does Arthrotek, Inc. have in the registry?
The registry currently lists 17 devices for Arthrotek, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Arthrotek, Inc.'s devices?
Among its 17 most recently registered devices, Arthrotek, Inc. has devices listed in FDA 510(k) (17 devices).
What risk classes do Arthrotek, Inc.'s devices fall under?
Among its 17 most recently registered devices, the classes recorded for Arthrotek, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Arthrotek, Inc. in the registry?
The most recently registered devices listed for Arthrotek, Inc. include ALLTHREAD LACTOSORB SUTURE ANCHOR, INNERVUE DIAGNOSTIC SCOPE SYSTEM, EZLOC FEMORAL FIXATION DEVICE and RESORBABLE INTERFERENCE SCREW.