FDA device listing
ANAX™ 5.5 SPINAL SYSTEM_SF5150CSM,ANAX™ 5.5 SPINAL SYSTEM_SF5150TSM,ANAX™ 5.5 SPINAL SYSTEM_SF5180CSM,ANAX™ 5.5 SPINAL…
FDA device listing 1833829086 · CGBIO USA, Inc.
Key facts
| Proprietary names | ANAX™ 5.5 SPINAL SYSTEM_SF5150CSM,ANAX™ 5.5 SPINAL SYSTEM_SF5150TSM,ANAX™ 5.5 SPINAL SYSTEM_SF5180CSM,ANAX™ 5.5 SPINAL SYSTEM_SF5180TSM,ANAX™ 5.5 SPINAL SYSTEM_SF5200CSM,ANAX™ 5.5 SPINAL SYSTEM_SF5200TSM,ANAX™ 5.5 SPINAL SYSTEM_SF6035CCM,ANAX™ 5.5 SPINAL SYSTEM_SF6035TCM,ANAX™ 5.5 SPINAL SYSTEM_SF6040CCM,ANAX™ 5.5 SPINAL SYSTEM_SF6040TCM,ANAX™ 5.5 SPINAL SYSTEM_SF6045CCM,ANAX™ 5.5 SPINAL… |
|---|---|
| Owner/operator | CGBIO USA, Inc. |
| Owner/operator number | 10094982 |
| Premarket submissions | K173524 |
| Product codes | NKB |
| Device names | NKB - Thoracolumbosacral Pedicle Screw System |
| Device class | Class II |
| Classification regulations (21 CFR) | 888.3070 |
| Review panels | Orthopedic |
| Registered establishments | CGBIO USA, INC. |
| Establishment registrations | 3039103971 |
| FEI numbers | 3039103971 |
| Establishment operations | Repackager/Relabeler |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1,000+ UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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