TruVision Single-Use 1.9mm Arthroscopy System (K260156): 510(k) cleared for Nexus CMF, LLC
TruVision Single-Use 1.9mm Arthroscopy System (K260156): 510(k) cleared for Nexus CMF, LLC (Utah): 510(k) cleared for Nexus CMF, LLC. Its amount of 262 is above the median of 138 (84th percentile). Dated 26 days ago, it is in the active follow-up window. Score 61/100. As of 2026-11-04, 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: 262 · 84th percentile of 414 FDAPulse records · 1.9x 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 | K260156 |
| Device | TruVision Single-Use 1.9mm Arthroscopy System |
| Applicant | Nexus CMF, LLC |
| Specialty / panel | Orthopedic |
| Product code | HRX |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-01-20 |
| Decision date | 2026-10-09 |
| Review time (days) | 262 |
| Third-party review | No |
| Applicant location | Salt Lake City, UT, US |
| amount percentile | 84th of 414 (median 138, 1.9x median) |
| Peer records CSV (11 UT records) | 🔒 Click to unlock → |
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CSV columns: Record · Specialty · Date · Review days · Recall class · official source URL
- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-10-09
- Data refreshed: 2026-11-04
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LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Wed, 04 Nov 2026 09:16:12 GMT
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Peer benchmark and outreach value: TruVision Single-Use 1.9mm Arthroscopy System (K260156): 510(k) cleared for Nexus CMF, LLC and 11 Utah peers
- Utah FDAPulse records like this one: 11
- TruVision Single-Use 1.9mm Arthroscopy System (K260156): 510(k) cleared for Nexus CMF, LLC's amount: 84th percentile of 414 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every Utah peer: $2,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
61 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- A long 262-day review suggests additional-information requests: a firm likely to value regulatory help next time.
- Posted 26 days ago.
What is the FDAPulse record for TruVision Single-Use 1.9mm Arthroscopy System (K260156): 510(k) cleared for Nexus CMF, LLC in Utah?
TruVision Single-Use 1.9mm Arthroscopy System (K260156) by Nexus CMF, LLC was cleared on 2026-10-09 after 262 days of review.
How does TruVision Single-Use 1.9mm Arthroscopy System (K260156): 510(k) cleared for Nexus CMF, LLC compare to other Utah FDAPulse records?
Its amount of 262 sits in the upper half (84th percentile) of 414 records; the median is 138. It is 26 days old, still within a typical 45-day follow-up window.
TruVision Single-Use 1.9mm Arthroscopy System (K260156) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| 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 |
| The VEGA Cervical Screw System (K254260) | KR | 2026-09-17 |
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