BIOSORB RESORBABLE VOID FILLER— 510(k) K021963

Name: FDA 510(k) clearance K021963
Creator: U.S. Food and Drug Administration
Published: 2003-01-28

Substantially Equivalent

Sciences ET Bio Materiaux (Sbm)

FDA 510(k) clearance K021963 for BIOSORB RESORBABLE VOID FILLER, Substantially Equivalent on 2003-01-28. Applicant: Sciences ET Bio Materiaux (Sbm). Device class: 2.

Clearance details

Applicant: Sciences ET Bio Materiaux (Sbm)
Product code: Code MQV
Device class: Class 2
Regulation: 21 CFR 888.3045
Advisory panel: Orthopedic
Date received: 2002-06-14
Decision date: 2003-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lourdes, FR

Download summary PDF View on FDA.gov ↗

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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 →

Recalls naming K021963

K-number listed on FDA's recall record

Z-1718-2025 — Bio 1 Granules for Filling ¿ 1 mm (2 cm¿), REF:P822692243, Material: BIOSORB (BTCP 95% minimum purity)Class II·Ongoing·SCIENCE & BIO MATERIALS·20250407

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K021963.

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