Formus Labs, Ltd.
NZ Last updated 22 Oct 2026
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- Devices
- 1
- Registries
- FDA 510(k)
- FDA recalls
- 0
Catalogue
Formus Hip Ref K213272
What Formus Labs, Ltd. makes
Formus Labs, Ltd. manufactures the Formus Hip, a medical device designed for hip joint replacement or repair procedures.
The Formus Hip is classified as a Class II device under FDA regulations and is listed in the FDA’s 510(k) clearance registry. The company is based in the United States.
Frequently asked questions
What types of medical devices does Formus Labs, Ltd. manufacture?
Formus Labs, Ltd. specializes in orthopedic medical devices, specifically producing the Formus Hip, which is designed for hip joint replacement or repair procedures. This device is intended to restore function and alleviate pain in patients with hip joint issues.
Where is Formus Labs, Ltd. based?
Formus Labs, Ltd. is headquartered in the United States. The company’s location is relevant for understanding its regulatory framework and operational reach, particularly in markets like the U.S.
How are the devices manufactured by Formus Labs, Ltd. classified under FDA regulations?
The Formus Hip, the primary device produced by Formus Labs, Ltd., is classified as a Class II medical device under FDA regulations. This classification typically means it poses moderate risk and requires premarket notification (510(k)) clearance to demonstrate substantial equivalence to a legally marketed predicate device.
Which regulatory registries list the devices made by Formus Labs, Ltd.?
The Formus Hip is listed in the FDA’s 510(k) clearance registry, which documents devices that have undergone the premarket notification process to demonstrate compliance with regulatory requirements. This registry helps healthcare professionals and regulators verify the device’s authorised status.
Information
- Country
- NZ