DeviceClearance

Aevumed SUPERCYNCH Button System— 510(k) K253065

Substantially Equivalent

Aevumed, Inc.

FDA 510(k) clearance K253065 for Aevumed SUPERCYNCH Button System, Substantially Equivalent on 2026-09-02. Applicant: Aevumed, Inc.. Device class: 2.

Summary

Aevumed SUPERCYNCH Button System is from Aevumed, Inc., filed under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue). The record gives no component list or sizes.

Class II, 21 CFR 888.3040. Orthopedic is both the classification panel and the review panel, and it came in as a Traditional 510(k). The decision was Substantially Equivalent.

Aevumed filed from Malvern, Pennsylvania. The decision came 345 calendar days after FDA received it (September 22, 2025 to September 2, 2026).

Clearance details

Applicant
Aevumed, Inc.
Product code
Product code MBI
Device class
Class 2
Regulation
21 CFR 888.3040
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Malvern, PA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code MBI

product code MBI
Injury
3,163
Malfunction
13,006
Other
2
Total
16,171

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.