FDA device listing
KyphX Handle; Introducer,MICRO-FRANCE Manual Surgical Instr,MULTIPLE Manual Surgical Instruments,Visualase,XOMED
FDA device listing 1529301254 · Medtronic, Inc.
Key facts
| Proprietary names | KyphX Handle; Introducer,MICRO-FRANCE Manual Surgical Instr,MULTIPLE Manual Surgical Instruments,Visualase,XOMED |
|---|---|
| Owner/operator | Medtronic, Inc. |
| Owner/operator number | 2112641 |
| Product codes | MDM |
| Device names | MDM - Instrument, Manual, Surgical, General Use |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4800 |
| Review panels | General & Plastic Surgery |
| Registered establishments | Medtronic Engineering and Innovation Center (MEIC), Medtronic Mexico S. de R.L. de CV, MEDTRONIC NAVIGATION, INC., MEDTRONIC XOMED, INC. |
| Establishment registrations | 1045254, 1723170, 9617601, 3018094310 |
| FEI numbers | 1045254, 1000517638, 3002534070, 3018094310 |
| Establishment operations | Complaint File Establishment, Manufacturer, Repackager/Relabeler |
| 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