OsteoCentric Technologies Cannulated and Soild Fasteners with Nuts (K263116): 510(k) cleared for OsteoCentric Technologies
OsteoCentric Technologies Cannulated and Soild Fasteners with Nuts (K263116): 510(k) cleared for OsteoCentric Technologies (Utah): 510(k) cleared for OsteoCentric Technologies. Its amount of 28 is below the median of 138 (6th percentile). Dated 33 days ago, it serves as a historical benchmark. Score 41/100. 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: 28 · 6th percentile of 414 FDAPulse records · 0.2x 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 | K263116 |
| Device | OsteoCentric Technologies Cannulated and Soild Fasteners with Nuts |
| Applicant | OsteoCentric Technologies |
| Specialty / panel | Orthopedic |
| Product code | HWC |
| Device class | 2 |
| Clearance type | Special |
| Decision | Substantially Equivalent |
| Received | 2026-09-04 |
| Decision date | 2026-10-02 |
| Review time (days) | 28 |
| Third-party review | No |
| Applicant location | Logan, UT, US |
| amount percentile | 6th of 414 (median 138, 0.2x 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: 2026-10-02
- 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: OsteoCentric Technologies Cannulated and Soild Fasteners with Nuts (K263116): 510(k) cleared for OsteoCentric Technologies and 11 Utah peers
- Utah FDAPulse records like this one: 11
- OsteoCentric Technologies Cannulated and Soild Fasteners with Nuts (K263116): 510(k) cleared for OsteoCentric Technologies's amount: 6th 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)
41 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 28-day review: this device is a strong predicate for similar products.
- Special 510(k): a modification of an existing device.
- Posted 33 days ago.
What is the FDAPulse record for OsteoCentric Technologies Cannulated and Soild Fasteners with Nuts (K263116): 510(k) cleared for OsteoCentric Technologies in Utah?
OsteoCentric Technologies Cannulated and Soild Fasteners with Nuts (K263116) by OsteoCentric Technologies was cleared on 2026-10-02 after 28 days of review.
How does OsteoCentric Technologies Cannulated and Soild Fasteners with Nuts (K263116): 510(k) cleared for OsteoCentric Technologies compare to other Utah FDAPulse records?
Its amount of 28 is below the median (6th percentile); smaller records often move faster and face less competition. It is 33 days old, still within a typical 45-day follow-up window.
OsteoCentric Technologies Cannulated and Soild Fasteners with Nuts (K263116) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| OsteoCentric Technologies Cannulated and Soild Fasteners with Nuts (K263116) | UT | 2026-10-02 |
| 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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