FDA device listing
BIO 1 Block for filling - 10x10x25 mm (2,5 cm3), Catalog Number P822694444,BIO 1 Block for filling - 10x10x25 mm (5…
FDA device listing 1917892823 · SCIENCE & BIO MATERIALS
Key facts
| Proprietary names | BIO 1 Block for filling - 10x10x25 mm (2,5 cm3), Catalog Number P822694444,BIO 1 Block for filling - 10x10x25 mm (5 cm3), Catalog Number P822694446,BIO 1 Cubes for filling - 10 x 10 x 10 mm (10 cm3), Catalog Number P822693624,BIO 1 Cubes for filling - 10 x 10 x 10 mm (15 cm3), Catalog Number P822693626,BIO 1 Cubes for filling - 10 x 10 x 10 mm (1 cm3), Catalog Number P822693620,BIO 1 Cubes for… |
|---|---|
| Owner/operator | SCIENCE & BIO MATERIALS |
| Owner/operator number | 9063735 |
| Premarket submissions | K021963 |
| Product codes | MQV |
| Device names | MQV - Filler, Bone Void, Calcium Compound |
| Device class | Class II |
| Classification regulations (21 CFR) | 888.3045 |
| Review panels | Orthopedic |
| Registered establishments | SCIENCE & BIO MATERIALS, S.B.M. SAS |
| Establishment registrations | 3004549189 |
| FEI numbers | 3004051158 |
| Establishment operations | Complaint File Establishment, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database