# Cgbio USA, Inc. (repackager or relabeler, Irvine, CA): 47 new FDA device listings, incl. orthosis, spinal pedicle fixation

**Score:** 75/100

| Field | Value |
|---|---|
| Establishment | Cgbio USA, Inc. |
| Owner / operator | CGBIO USA, Inc. |
| Role | Repackager or relabeler |
| Establishment types | Repack or Relabel Medical Device |
| Location | Irvine, CA, US |
| New listings | 47 |
| Devices | Orthosis, Spinal Pedicle Fixation; Orthosis, Spondylolisthesis Spinal Fixation; Reamer; Appliance, Fixation, Spinal Interlaminal; Thoracolumbosacral Pedicle Screw System; Plate, Cranioplasty, Preformed, Non-Alterable; Rod, Fixation, Intramedullary And Accessories; Posterior Cervical Screw System; Intervertebral Fusion Device With Bone Graft, Cervical; Intervertebral Fusion Device With Bone Graft, Lumbar |
| Product codes | MNI, MNH, HTO, KWP, NKB, GXN, HSB, NKG, ODP, MAX, KWQ, HTY, HXX, OVE, HTW |
| Device classes | Class I, Class II, Unclassified |
| Medical specialties | Orthopedic, Neurology |
| Brand names | Perfix™ Spinal System; NGS1033; NGS1034; Iliac Screw System; INNOVERSE Spinal System; EASYMADE-TI; Dyna Locking Trochanteric Nail™; ANAX™ OCT SPINAL SYSTEM |
| First new listing | 2026-05-13 |
| Latest new listing | 2026-10-13 |
| FDA registration number | 3039103971 |
| Registration expires | 2027-12-31 |

## Why this score
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- U.S. establishment.
- Listed in the last 45 days.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-10-28T20:51:27.468Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.