Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis HAtetracell®-C Titanium Cervical IBF System (K262025): 510(k) cleared for INNO Holdings Inc. DBA Innovasis
Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis HAtetracell®-C Titanium Cervical IBF System (K262025): 510(k) cleared for INNO Holdings Inc. DBA Innovasis (Utah): 510(k) cleared for INNO Holdings Inc. DBA Innovasis. Its amount of 87 is below the median of 138 (27th percentile). Dated 54 days ago, it serves as a historical benchmark. Score 30/100. As of 2026-11-03, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
amount: 87 · 27th percentile of 414 FDAPulse records · 0.6x the median
Free preview: all 14 published fields of this record are shown below. Locked: 10 related UT FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K262025 |
| Device | Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis HAtetracell®-C Titanium Cervical IBF System |
| Applicant | INNO Holdings Inc. DBA Innovasis |
| Specialty / panel | Orthopedic |
| Product code | OVD |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-06-16 |
| Decision date | 2026-09-11 |
| Review time (days) | 87 |
| Third-party review | No |
| Applicant location | Salt Lake City, UT, US |
| amount percentile | 27th of 414 (median 138, 0.6x median) |
| Peer records CSV (11 UT records) | 🔒 Click to unlock → |
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- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-09-11
- Data refreshed: 2026-11-03
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Tue, 03 Nov 2026 18:05:14 GMT
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Peer benchmark and outreach value: Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis HAtetracell®-C Titanium Cervical IBF System (K262025): 510(k) cleared for INNO Holdings Inc. DBA Innovasis and 11 Utah peers
- Utah FDAPulse records like this one: 11
- Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis HAtetracell®-C Titanium Cervical IBF System (K262025): 510(k) cleared for INNO Holdings Inc. DBA Innovasis's amount: 27th percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Utah peer: $2,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
30 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 87-day review: this device is a strong predicate for similar products.
What is the FDAPulse record for Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis HAtetracell®-C Titanium Cervical IBF System (K262025): 510(k) cleared for INNO Holdings Inc. DBA Innovasis in Utah?
Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis HAtetracell®-C Titanium Cervical IBF System (K262025) by INNO Holdings Inc. DBA Innovasis was cleared on 2026-09-11 after 87 days of review.
How does Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis HAtetracell®-C Titanium Cervical IBF System (K262025): 510(k) cleared for INNO Holdings Inc. DBA Innovasis compare to other Utah FDAPulse records?
Its amount of 87 is below the median (27th percentile); smaller records often move faster and face less competition. It is 54 days old; check the official source for later updates before acting. Its Predicate Speed & CAPA Advisory Opportunity Score of 30/100 is modest; treat it as background rather than a priority.
Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis HAtetracell®-C Titanium Cervical IBF System (K262025) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis HAtetracell®-C Titanium Cervical IBF System (K262025) | UT | 2026-09-11 |
| TruVision Single-Use 1.9mm Arthroscopy System (K260156) | UT | 2026-10-09 |
| Kentrospine Viktr-MIS® Pedicle screw system (K252139) | IN | 2026-09-27 |
| F.A.S.T Screw (K254280) | FR | 2026-09-21 |
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