BIOSORB RESORBABLE VOID FILLER
FDA 510(k) clearance K021963 · decided 2003-01-28
Clearance details
- K-number
- K021963
- Device name
- BIOSORB RESORBABLE VOID FILLER
- Applicant
- Sciences ET Bio Materiaux (Sbm)
- Decision
- Substantially Equivalent
- Date received
- 2002-06-14
- Decision date
- 2003-01-28
- Days to decision
- 228 days
- Clearance type
- Traditional
- Product code
- MQV
- Device class
- 2
- Regulation number
- 888.3045
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Lourdes, FR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Bio 1 Granules for Filling 1 mm (2 cm), REF:P822692243, Material: BIOSORB (BTCP 95% minimu recall (Z-1718-2025) | SCIENCE & BIO MATERIALS | 2025-05-02 |