Instratek, Inc.
United StatesFDA applicant, unverified
- Devices
- 10
What Instratek, Inc. makes
Instratek, Inc. manufactures orthopedic and trauma fixation devices, including cannulated screws, fracture fixation systems, superelastic bone staples, and endoscopic instruments for carpal tunnel and Morton’s neuroma procedures. Their portfolio also includes specialized foot and ankle correction systems, such as the Sub-Talar LOK and HAV-LOK, as well as cable fixation tools for joint stabilization.
All listed devices fall under Class II regulatory classification in the U.S. and are recorded in the FDA 510(k) database. The company operates from the United States, adhering to U.S. medical device regulations.
Catalogue
Mini Cannulated Headed And Headless Screw Set Ref K120493
Regimes: 510(k) Registry: 510(k)Jones-Fx Fracture System Ref K131620
Regimes: 510(k) Registry: 510(k)Stapix Superelastic Implant Bone Staples Ref K133523
Regimes: 510(k) Registry: 510(k)Endoscopic Carpal Tunnel Instruments Ref K922391
Regimes: 510(k) Registry: 510(k)Endoscopic Mortons Neuroma Instruments Ref K940230
Regimes: 510(k) Registry: 510(k)Sub-Talar Lok, Model 7-11 Mm Ref K080280
Regimes: 510(k) Registry: 510(k)Michelangelo Bunion System - Mabs, Model: MA6000 Ref K091763
Regimes: 510(k) Registry: 510(k)Cmc Cable Fix Ref K111032
Regimes: 510(k) Registry: 510(k)Endotrak System Ref K925083
Regimes: 510(k) Registry: 510(k)Hav-Lok Bunion Correction System Ref K082384
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Instratek, Inc. have in the registry?
The registry currently lists 10 devices for Instratek, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Instratek, Inc.'s devices?
Among its 10 most recently registered devices, Instratek, Inc. has devices listed in FDA 510(k) (10 devices).
What risk classes do Instratek, Inc.'s devices fall under?
Among its 10 most recently registered devices, the classes recorded for Instratek, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Instratek, Inc. in the registry?
The most recently registered devices listed for Instratek, Inc. include MINI CANNULATED HEADED AND HEADLESS SCREW SET, JONES-FX FRACTURE SYSTEM, STAPIX SUPERELASTIC IMPLANT BONE STAPLES and ENDOSCOPIC CARPAL TUNNEL INSTRUMENTS.