FDA.report

510(k) K242895

Device
Aevumed PHANTOM Suture Anchors
Applicant
Aevumed, Inc.
510(k) number
K242895
Product code
MBI
Decision
Substantially Equivalent (SESE)
Decision date
2025-08-06
Date received
2024-09-23
Regulation
888.3040
Classification name
Fastener, Fixation, Nondegradable, Soft Tissue
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Saif Khalil
Address
109 Great Valley Pkwy. Malvern PA US 19355 19355

FDA Registration Numbers

Source Documents

510(k) summary PDF

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