FDA device listing
Abyrx4508 (WH) - Montage Settable Bone Putty,Abyrx4508 (WH) - Montage Settable, Resorbable Bone Putty
FDA device listing 2028954924 · STERIS Corporation
Key facts
| Proprietary names | Abyrx4508 (WH) - Montage Settable Bone Putty,Abyrx4508 (WH) - Montage Settable, Resorbable Bone Putty |
|---|---|
| Owner/operator | STERIS Corporation |
| Owner/operator number | 1527821 |
| Product codes | MQV, OIS |
| Device names | MQV - Filler, Bone Void, Calcium Compound, OIS - Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation |
| Device class | Class II |
| Classification regulations (21 CFR) | 888.3045 |
| Review panels | Orthopedic |
| Registered establishments | ISOMEDIX OPERATIONS INC. |
| Establishment registrations | 2245304 |
| FEI numbers | 2245304 |
| Establishment operations | Contract Sterilizer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed 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