Alpha AI Co., Ltd. (manufacturer, PYEONGTAEK Gyeonggi, KR): 4 new FDA device listings, incl. appliance, fixation, spinal intervertebral body
Alpha AI Co., Ltd. (PYEONGTAEK Gyeonggi): 4 new FDA device listings, incl. appliance, fixation, spinal intervertebral body. Its amount of 4 is above the median of 2 (83rd percentile). Dated 146 days ago, it serves as a historical benchmark. Score 75/100. As of 2026-11-04, 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: 4 · 83th percentile of 2,709 DeviceEstablishmentPulse records · 2.0x the median
Free preview: all 14 published fields of this record are shown below. Locked: 121 related KR DeviceEstablishmentPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Establishment | Alpha AI Co., Ltd. |
| Role | Manufacturer |
| Establishment types | Manufacture Medical Device |
| Location | PYEONGTAEK Gyeonggi, KR |
| New listings | 4 |
| Devices | Appliance, Fixation, Spinal Intervertebral Body; Thoracolumbosacral Pedicle Screw System; Appliance, Fixation, Spinal Interlaminal |
| Product codes | KWQ, NKB, KWP |
| Device classes | Class II |
| Medical specialties | Orthopedic |
| Brand names | 4CIS® Chiron Spinal Fixation System |
| First new listing | 2026-06-12 |
| Latest new listing | 2026-06-12 |
| FDA registration number | 3004941535 |
| Registration expires | 2026-12-31 |
| amount percentile | 83th of 2,709 (median 2, 2.0x median) |
| Peer records CSV (122 KR 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: 2026-06-12
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) · Last refreshed: Wed, 04 Nov 2026 21:52:36 GMT
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Peer benchmark and outreach value: Alpha AI Co., Ltd. and 122 KR peers
- KR DeviceEstablishmentPulse records like this one: 122
- Alpha AI Co., Ltd.'s amount: 83rd percentile of 2,709 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every KR peer: $24,400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
75 / 100 Score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
What is the DeviceEstablishmentPulse record for Alpha AI Co., Ltd. in PYEONGTAEK Gyeonggi?
Alpha AI Co., Ltd. (PYEONGTAEK Gyeonggi, KR), a manufacturer, added 4 FDA device listings on 2026-06-12.
How does Alpha AI Co., Ltd. compare to other DeviceEstablishmentPulse records?
Its amount of 4 sits in the upper half (83th percentile) of 2,709 records; the median is 2. It is 146 days old; check the official source for later updates before acting. Its Score of 75/100 puts it among the stronger signals in this feed.
Alpha AI Co., Ltd. vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Alpha AI Co., Ltd. | PYEONGTAEK Gyeonggi, KR | 4 | 83rd | 2026-06-12 |
| Applied Medical Resources Corp. | Rsm, CA | 3 | 77th | 2026-10-23 |
| Inter-Med, Inc. | Racine, WI | 5 | 86th | 2026-10-22 |
| Centerpoint Systems LLC | West Valley City, UT | 5 | 86th | 2026-10-21 |
Related records
- Applied Medical Resources Corp.
- Inter-Med, Inc.
- Intuitive Surgical, Inc.
- Biomerieux, Inc.
- Intuitive Surgical, Inc.
- Masimo Corporation
- Centerpoint Systems LLC
- Tornier, Inc.
- Treace Medical Concepts, Inc.
- Coopersurgical, Inc.
- GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC
- Boston Scientific Corporation
DeviceEstablishmentPulse: Manufacturer DeviceEstablishmentPulse: Foreign establishment
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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.