FDA device listing
ARMS WELDMENT, PUSH ARM,ARMS WELDMENT, ROD ARM,Bone Screw Inserter Driver, Cannulated,Cannulated Screw Inserter…
FDA device listing 1650033681 · SOLCO BIOMEDICAL CO
Key facts
| Proprietary names | ARMS WELDMENT, PUSH ARM,ARMS WELDMENT, ROD ARM,Bone Screw Inserter Driver, Cannulated,Cannulated Screw Inserter Shaft,Extended Tab Pusher - Bar End,Low Top Pusher - Bar End,Modular Tulip Inseter quick connect carrier,Outer Sleeve,Pusher Bar Shaft,Reduction Pusher - Bar End,Retention Sleeve,Set Screw Inserter,Set Screw Tightener,Threaded Knob,Tightener Sleeve,Tower |
|---|---|
| Owner/operator | SOLCO BIOMEDICAL CO |
| Owner/operator number | 10077960 |
| Product codes | KWP, KWQ, NKB, OLO |
| Device names | KWP - Appliance, Fixation, Spinal Interlaminal, KWQ - Appliance, Fixation, Spinal Intervertebral Body, NKB - Thoracolumbosacral Pedicle Screw System, OLO - Orthopedic Stereotaxic Instrument |
| Device class | Class II |
| Classification regulations (21 CFR) | 882.4560, 888.3050, 888.3060, 888.3070 |
| Review panels | Neurology, Orthopedic |
| Registered establishments | SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED |
| Establishment registrations | 3016443334 |
| FEI numbers | 3016443334 |
| 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