Aevumed, Inc.
United StatesFDA applicant, unverified FDA FEI 3022393834
- Devices
- 8
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Aevumed, Inc. makes
Aevumed, Inc. manufactures a range of suture anchors designed for orthopedic and sports medicine applications, including the PHANTOM, FENIX, RAPID, PHANTOM-LP, PROTEKT, and FASE series. These devices are intended for securing soft tissue to bone, such as in rotator cuff repairs or ligament reconstructions.
The company’s suture anchors are classified as Class II medical devices under FDA regulations and are supported by 510(k) clearance. The products are listed in the FDA’s 510(k) database, reflecting their regulatory status in the United States.
Catalogue
Aevumed SUPERCYNCH™ Button System Ref K253065
Regimes: 510(k) Registry: 510(k)AEVUMED PHANTOM Suture Anchors Ref K180464
Regimes: 510(k) Registry: 510(k)Aevumed FENIX Suture Anchor Ref K254306
Regimes: 510(k) Registry: 510(k)Aevumed PHANTOM Suture Anchors Ref K242895
Regimes: 510(k) Registry: 510(k)Aevumed RAPID Suture Anchors Ref K223878
Regimes: 510(k) Registry: 510(k)Aevumed PHANTOM™-LP Suture Anchors Ref K222363
Regimes: 510(k) Registry: 510(k)Aevumed PROTEKT Suture Anchor Ref K260004
Regimes: 510(k) Registry: 510(k)Aevumed FASE Suture Anchor Ref K253040
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3022393834
- Address
- 109 Great Valley Pkwy, Malvern, PA, 19355
Frequently asked questions
How many devices does Aevumed, Inc. have in the registry?
The registry currently lists 8 devices for Aevumed, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Aevumed, Inc.'s devices?
Among its 8 most recently registered devices, Aevumed, Inc. has devices listed in FDA 510(k) (8 devices).
What risk classes do Aevumed, Inc.'s devices fall under?
Among its 8 most recently registered devices, the classes recorded for Aevumed, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Aevumed, Inc. in the registry?
The most recently registered devices listed for Aevumed, Inc. include Aevumed SUPERCYNCH™ Button System, AEVUMED PHANTOM Suture Anchors, Aevumed FENIX Suture Anchor and Aevumed RAPID Suture Anchors.