FDA device listing
implacross® E PE insert 0 4mm offset ID = 02353239,implacross® E PE insert 0 4mm offset ID = 02353244,implacross® E PE…
FDA device listing 1156036422 · Rose GmbH fuer Medizintechnik
Key facts
| Proprietary names | implacross® E PE insert 0 4mm offset ID = 02353239,implacross® E PE insert 0 4mm offset ID = 02353244,implacross® E PE insert 0 4mm offset ID = 02353248,implacross® E PE insert 0 4mm offset ID = 02353252,implacross® E PE insert 0 4mm offset ID = 02353644,implacross® E PE insert 0 4mm offset ID = 02353648,implacross® E PE insert 0 4mm offset ID = 02353652,implacross® E PE insert 10 4mm offset ID =… |
|---|---|
| Owner/operator | Rose GmbH fuer Medizintechnik |
| Owner/operator number | 10042910 |
| Product codes | LZO |
| Device names | LZO - Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented |
| Device class | Class II |
| Classification regulations (21 CFR) | 888.3353 |
| Review panels | Orthopedic |
| Registered establishments | ROSE GMBH FUER MEDIZINTECHNIK |
| Establishment registrations | 3002808022 |
| FEI numbers | 3002808022 |
| 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