Morpheus® Moldable; Agilon® Moldable— 510(k) K240621

Name: FDA 510(k) clearance K240621
Creator: U.S. Food and Drug Administration
Published: 2024-04-30

Substantially Equivalent

Biogennix, LLC

FDA 510(k) clearance K240621 for Morpheus® Moldable; Agilon® Moldable, Substantially Equivalent on 2024-04-30. Applicant: Biogennix, LLC. Device class: 2.

Clearance details

Applicant: Biogennix, LLC
Product code: Code MQV
Device class: Class 2
Regulation: 21 CFR 888.3045
Advisory panel: Orthopedic
Date received: 2024-03-05
Decision date: 2024-04-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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K193487 — Agilon Strip2020-03-30
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K181337 — Sypher Spacer System2018-09-18
K141798 — SYPHER SPACER SYSTEM2015-02-19

Adverse events under product code MQV

product code MQV

Death: 6
Injury: 435
Total: 441

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.