FDA device listing
OTIS 50 implant - Height 10mm, Catalog Number P822667230,OTIS 50 implant - Height 11mm, Catalog Number P822667232,OTIS…
FDA device listing 1479517109 · SCIENCE & BIO MATERIALS
Key facts
| Proprietary names | OTIS 50 implant - Height 10mm, Catalog Number P822667230,OTIS 50 implant - Height 11mm, Catalog Number P822667232,OTIS 50 implant - Height 12mm, Catalog Number P822667234,OTIS 50 implant - Height 13mm, Catalog Number P822667236,OTIS 50 implant - Height 14mm, Catalog Number P822667238,OTIS 50 implant - Height 15mm, Catalog Number P822667240,OTIS 50 implant - Height 6mm, Catalog Number… |
|---|---|
| Owner/operator | SCIENCE & BIO MATERIALS |
| Owner/operator number | 9063735 |
| Premarket submissions | K071155 |
| 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