Cgbio USA, Inc. (repackager or relabeler, Irvine, CA): 47 new FDA device listings, incl. orthosis, spinal pedicle fixation
Cgbio USA, Inc. (Irvine, California): 47 new FDA device listings, incl. orthosis, spinal pedicle fixation. Its amount of 47 is top-decile (99th percentile of 2,570 records). Dated 23 days ago, it is in the active follow-up window. Score 75/100. As of 2026-10-28, from openFDA device registration and listing endpoint (U.S. Food and Drug Administration).
Data as of · Compiled by Zalwin from openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
amount: 47 · 99th percentile of 2,570 DeviceEstablishmentPulse records · 47.0x the median
Free preview: all 15 published fields of this record are shown below. Locked: 283 related CA DeviceEstablishmentPulse records and the 5-column CSV export.
| 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 |
| amount percentile | 99th of 2,570 (median 1, 47.0x median) |
| Peer records CSV (284 CA records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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CSV columns: Establishment · Role · New listings · Devices · Latest listing · official source URL
- Source agency: openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
- Record date: 2026-10-13
- Data refreshed: 2026-10-28
- Refunds on request within 14 days
Top DeviceEstablishmentPulse records (CA first): Icu Medical, Inc. (specification developer, San Clemente, CA · Innopex Limited (foreign exporter, Toronto Ontario, CA) · Can Technomed Trading Ltd. (foreign exporter, Richmond Briti · Jmu Dental, Inc (repackager or relabeler, Fullerton, CA) · Skyward Medical Devices LLC (repackager or relabeler, Eastva · Browse all by state and category →
LIVE PUBLIC DATA Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) · Last refreshed: Wed, 28 Oct 2026 20:51:27 GMT
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Peer benchmark and outreach value: Cgbio USA, Inc. and 284 California peers
- California DeviceEstablishmentPulse records like this one: 284
- Cgbio USA, Inc.'s amount: 99th percentile of 2,570 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every California peer: $56,800 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
75 / 100 Score
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- U.S. establishment.
- Listed in the last 45 days.
What is the DeviceEstablishmentPulse record for Cgbio USA, Inc. in Irvine, California?
Cgbio USA, Inc. (Irvine, CA), a repackager or relabeler, added 47 FDA device listings between 2026-05-13 and 2026-10-13.
How does Cgbio USA, Inc. compare to other California DeviceEstablishmentPulse records?
This is a top-decile record: its amount of 47 is 47.0x the median of 1 across 2,570 records. It is 23 days old, still within a typical 45-day follow-up window. Its Score of 75/100 puts it among the stronger signals in this feed.
Cgbio USA, Inc. vs. top 2 peers
| Organization | Location | Amount | Percentile | Record date | Compare |
|---|---|---|---|---|---|
| Cgbio USA, Inc. | Irvine, CA | 47 | 99th | 2026-10-13 | This record |
| Jmu Dental, Inc | Fullerton, CA | 31 | 98th | 2026-09-29 | Compare Cgbio USA, Inc. vs Jmu Dental, Inc → |
| Tpc Advanced Technology, Inc. | City Industry, CA | 4 | 83rd | 2026-09-28 | View record → |
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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.