Prime BIOFOAM® Multi-Hole Shells— 510(k) K201157

Name: FDA 510(k) clearance K201157
Creator: U.S. Food and Drug Administration
Published: 2021-08-24

Substantially Equivalent

Microport Orthopedics, Inc.

FDA 510(k) clearance K201157 for Prime BIOFOAM® Multi-Hole Shells, Substantially Equivalent on 2021-08-24. Applicant: Microport Orthopedics, Inc.. Device class: 2.

Clearance details

Applicant: Microport Orthopedics, Inc.
Product code: Code MBL
Device class: Class 2
Regulation: 21 CFR 888.3358
Advisory panel: Orthopedic
Date received: 2020-04-30
Decision date: 2021-08-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arlington, TN, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MBL

product code MBL

Injury: 439
Total: 439

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.