FDA device listing
Chronoceptor,MetaStep Displacement Device,MetaStep Positioning Screw,MetaStep Saw Template,MetaStep Stamp,MetaStep…
FDA device listing 1548535132 · Aristotech Industries GmbH
Key facts
| Proprietary names | Chronoceptor,MetaStep Displacement Device,MetaStep Positioning Screw,MetaStep Saw Template,MetaStep Stamp,MetaStep Steinmann Nail,OsteoBridge IKA Knee Arthrodesis Cement Protection Cap,OsteoBridge IKA Knee Arthrodesis Distance Holder,OsteoBridge IKA Knee Arthrodesis Torque Limiter,OsteoBridge Trocar,Rasp Handle,T-Handle,Various handles with ratchet,Wirefix Retractor |
|---|---|
| Owner/operator | Aristotech Industries GmbH |
| Owner/operator number | 10053573 |
| Product codes | LXH |
| Device names | LXH - Orthopedic Manual Surgical Instrument |
| Device class | Class I |
| Classification regulations (21 CFR) | 888.4540 |
| Review panels | Orthopedic |
| Registered establishments | Aristotech Industries GmbH |
| Establishment registrations | 3014314623 |
| FEI numbers | 3014314623 |
| Establishment operations | Contract Manufacturer |
| 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