Orthoconcept, Inc.
United StatesFDA applicant, unverified
- Devices
- 8
What Orthoconcept, Inc. makes
Orthoconcept, Inc. manufactures arthroscopic disposable and reusable shaver blades, rechargeable systems, and fluid management solutions for joint surgery. Their portfolio includes irrigation sets, pumps for arthroscopic procedures, and components like blades, rechargers, and batteries designed for orthopedic applications. The company also produces a modified fluid management system for urological procedures.
These devices are classified as Class II under FDA regulations and are supported by 510(k) clearances. The company is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Modified Uropump* Fluid Management System Ref K895643
Regimes: 510(k) Registry: 510(k)Orthoconcept Arthroscopic Pump Ref K910164
Regimes: 510(k) Registry: 510(k)Cordex Shaver, Blades, Recharger And Batteries Ref K882469
Regimes: 510(k) Registry: 510(k)Uropump* Fluid Management System Ref K894363
Regimes: 510(k) Registry: 510(k)Arthro-Fms-3/Irrigation Sets (Various) Ref K905785
Regimes: 510(k) Registry: 510(k)Orthoconcept Arthroscopic Pump Orthopump Ref K872270
Regimes: 510(k) Registry: 510(k)Arthro Fms 4 Ref K925160
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Orthoconcept, Inc. have in the registry?
The registry currently lists 8 devices for Orthoconcept, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Orthoconcept, Inc.'s devices?
Among its 8 most recently registered devices, Orthoconcept, Inc. has devices listed in FDA 510(k) (8 devices).
What risk classes do Orthoconcept, Inc.'s devices fall under?
Among its 8 most recently registered devices, the classes recorded for Orthoconcept, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Orthoconcept, Inc. in the registry?
The most recently registered devices listed for Orthoconcept, Inc. include ARTHROSCOPY DISP. & REUSABLE SHAVER BLADES, RECHAR, MODIFIED UROPUMP* FLUID MANAGEMENT SYSTEM, ORTHOCONCEPT ARTHROSCOPIC PUMP and CORDEX SHAVER, BLADES, RECHARGER AND BATTERIES.