510(k) K021963 ยท MQV Filler, Bone Void, Calcium Compound
BIOSORB RESORBABLE VOID FILLER
| Applicant | Sciences ET Bio Materiaux (Sbm), Lourdes, FR |
| Decision | Substantially Equivalent, Jan 28, 2003 |
| Received | Jun 14, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K021963
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 2, 2025 | SCIENCE & BIO MATERIALS Bio 1 Granules for Filling 1 mm (2 cm), REF:P822692243, Material: BIOSORB (BTCP 95% minimum purity) Open, Classified |
MQV | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.