Pegasus Biologics, Inc.
United StatesFDA applicant, unverified
- Devices
- 5
What Pegasus Biologics, Inc. makes
Pegasus Biologics, Inc. manufactures biomaterial-based medical devices, including orthopedic implants like the UNITE BIOMATRIX and ORTHADAPT PR for bone repair, as well as the ORTHADAPT BIOIMPLANT for surgical applications. Their portfolio also includes the DERMADAPT WOUND DRESSING for skin repair and the PEGASUS BIOLOGICS ORTHADAPT SURGICAL MESH for soft tissue reinforcement.
These devices are regulated under FDA Class II and Class U classifications, with submissions supported via the 510(k) pathway. The company’s products are listed in the FDA’s 510(k) registry, and the manufacturer is based in the United States.
Catalogue
Unite Biomatrix Ref K071425
Regimes: 510(k) Registry: 510(k)Orthadapt Pr Ref K090288
Regimes: 510(k) Registry: 510(k)Orthadapt Bioimplant Ref K071065
Regimes: 510(k) Registry: 510(k)Dermadapt Wound Dressing Ref K061494
Regimes: 510(k) Registry: 510(k)Pegasus Biologics Orthadapt Surgical Mesh Ref K043388
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Pegasus Biologics, Inc. have in the registry?
The registry currently lists 5 devices for Pegasus Biologics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Pegasus Biologics, Inc.'s devices?
Among its 5 most recently registered devices, Pegasus Biologics, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Pegasus Biologics, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Pegasus Biologics, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Pegasus Biologics, Inc. in the registry?
The most recently registered devices listed for Pegasus Biologics, Inc. include UNITE BIOMATRIX, ORTHADAPT PR, ORTHADAPT BIOIMPLANT and DERMADAPT WOUND DRESSING.