FDA device listing
10K, Linvatec,ADVANTAGE 2,C-SERTER,HALL DRILL REAM ATTACHMENT,MICRO 100 TUBING,POWERPRO,PowerPro Attachments,POWERPROMAX…
FDA device listing 1748341393 · CONMED CORPORATION
Key facts
| Proprietary names | 10K, Linvatec,ADVANTAGE 2,C-SERTER,HALL DRILL REAM ATTACHMENT,MICRO 100 TUBING,POWERPRO,PowerPro Attachments,POWERPROMAX DRIVER ATTACHMENT,UNIVERSAL CABLE |
|---|---|
| Owner/operator | CONMED CORPORATION |
| Owner/operator number | 1317214 |
| Product codes | HWE |
| Device names | HWE - Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4820 |
| Review panels | General & Plastic Surgery |
| Registered establishments | CONMED CORPORATION, Consolidated Medical Equipment Company, Linvatec Corporation |
| Establishment registrations | 1017294, 1320894, 3007305485 |
| FEI numbers | 1017294, 3001451571, 3007305485 |
| Establishment operations | Complaint File Establishment, Manufacturer, Contract Manufacturer, Specification Developer |
| 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