Medical Device Manufacturer · US , Malvern , PA

Aevumed, Inc. - FDA 510(k) Cleared Devices

8 submissions · 8 cleared · Since 2018

Recent clearances: Aevumed SUPERCYNCH™ Button System, Aevumed FENIX Suture Anchor, Aevumed PROTEKT Suture Anchor

View 8 510(k) Devices ↓ Official Website
8
Total
8
Cleared
0
Denied

FDA 510(k) Regulatory Record - Aevumed, Inc. Orthopedic ✕

8 devices
1-8 of 8
Cleared Sep 02, 2026
Aevumed SUPERCYNCH™ Button System
K253065 · MBI
Orthopedic · 345d
Cleared Mar 04, 2026
Aevumed FENIX Suture Anchor
K254306 · MBI
Orthopedic · 63d
Cleared Jan 28, 2026
Aevumed PROTEKT Suture Anchor
K260004 · MBI
Orthopedic · 26d
Cleared Oct 21, 2025
Aevumed FASE Suture Anchor
K253040 · MBI
Orthopedic · 29d
Cleared Aug 06, 2025
Aevumed PHANTOM Suture Anchors
K242895 · MBI
Orthopedic · 317d
Cleared Mar 17, 2023
Aevumed RAPID Suture Anchors
K223878 · MBI
Orthopedic · 80d
Cleared Nov 28, 2022
Aevumed PHANTOM™-LP Suture Anchors
K222363 · MBI
Orthopedic · 116d
Cleared May 31, 2018
AEVUMED PHANTOM Suture Anchors
K180464 · MBI
Orthopedic · 99d
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