INNO Holdings Inc. (manufacturer, Millcreek, UT): 3 new FDA device listings, incl. intervertebral fusion device with integrated fixation, lumbar
INNO Holdings Inc. (Millcreek, Utah): 3 new FDA device listings, incl. intervertebral fusion device with integrated fixation, lumbar. Its amount of 3 is above the median of 2 (77th percentile). Dated 31 days ago, it serves as a historical benchmark. Score 95/100. 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: 3 · 77th percentile of 2,709 DeviceEstablishmentPulse records · 1.5x the median
Free preview: all 15 published fields of this record are shown below. Locked: 34 related UT DeviceEstablishmentPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Establishment | INNO Holdings Inc. |
| Owner / operator | Inno Holdings Inc. |
| Role | Manufacturer |
| Establishment types | Manufacture Medical Device |
| Location | Millcreek, UT, US |
| New listings | 3 |
| Devices | Intervertebral Fusion Device With Integrated Fixation, Lumbar; Intervertebral Fusion Device With Bone Graft, Cervical; Intervertebral Fusion Device With Bone Graft, Lumbar |
| Product codes | OVD, ODP, MAX |
| Device classes | Class II |
| Medical specialties | Orthopedic |
| Brand names | Innovasis AxTiHA® Stand-Alone ALIF System; Innovasis TxTiHA® IBF System; Innovasis HAtetracell®-C Titanium Cervical IBF System |
| First new listing | 2026-10-05 |
| Latest new listing | 2026-10-05 |
| FDA registration number | 3004719693 |
| Registration expires | 2027-12-31 |
| amount percentile | 77th of 2,709 (median 2, 1.5x median) |
| Peer records CSV (35 UT 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: 2026-10-05
- 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: INNO Holdings Inc. and 35 Utah peers
- Utah DeviceEstablishmentPulse records like this one: 35
- INNO Holdings Inc.'s amount: 77th percentile of 2,709 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Utah peer: $7,000 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
95 / 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.
- U.S. establishment.
- Listed in the last 45 days.
What is the DeviceEstablishmentPulse record for INNO Holdings Inc. in Millcreek, Utah?
INNO Holdings Inc. (Millcreek, UT), a manufacturer, added 3 FDA device listings on 2026-10-05.
How does INNO Holdings Inc. compare to other Utah DeviceEstablishmentPulse records?
Its amount of 3 sits in the upper half (77th percentile) of 2,709 records; the median is 2. It is 31 days old, still within a typical 45-day follow-up window. Its Score of 95/100 puts it among the stronger signals in this feed.
INNO Holdings Inc. vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| INNO Holdings Inc. | Millcreek, UT | 3 | 77th | 2026-10-05 |
| Applied Medical Resources Corp. | Rsm, CA | 3 | 77th | 2026-10-23 |
| Tornier, Inc. | Bloomington, MN | 3 | 77th | 2026-10-21 |
| Treace Medical Concepts, Inc. | Ponte Vedra, FL | 3 | 77th | 2026-10-20 |
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: U.S. establishment DeviceEstablishmentPulse: records in Utah
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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.