iFuse Granite Onyx Implant System (K262067): 510(k) cleared for SI-BONE, Inc.
iFuse Granite Onyx Implant System (K262067): 510(k) cleared for SI-BONE, Inc. (California): 510(k) cleared for SI-BONE, Inc. Its amount of 93 is below the median of 138 (33rd percentile). Dated 42 days ago, it serves as a historical benchmark. Score 36/100. 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: 93 · 33th percentile of 414 FDAPulse records · 0.7x the median
Free preview: all 14 published fields of this record are shown below. Locked: 75 related CA FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K262067 |
| Device | iFuse Granite Onyx Implant System |
| Applicant | SI-BONE, Inc. |
| Specialty / panel | Orthopedic |
| Product code | NKB |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-06-22 |
| Decision date | 2026-09-23 |
| Review time (days) | 93 |
| Third-party review | No |
| Applicant location | Santa Clara, CA, US |
| amount percentile | 33th of 414 (median 138, 0.7x median) |
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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: 2026-09-23
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
Top FDAPulse records (CA first): Triever Duo Catheter (K253419) · Helo Return (K253717) · DistaSense(TM) (v1) (K254058) · BD OneFlow LST; BD OneFlow B-CLPD T1; BD FACSLyric Flow Cyto · CapsoView (CVV); CapsoCloud (CLD) (K254230) · Browse all by state and category →
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: iFuse Granite Onyx Implant System (K262067): 510(k) cleared for SI-BONE, Inc. and 76 California peers
- California FDAPulse records like this one: 76
- iFuse Granite Onyx Implant System (K262067): 510(k) cleared for SI-BONE, Inc.'s amount: 33rd percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every California peer: $15,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
36 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 93-day review: this device is a strong predicate for similar products.
- Posted 42 days ago.
What is the FDAPulse record for iFuse Granite Onyx Implant System (K262067): 510(k) cleared for SI-BONE, Inc. in California?
iFuse Granite Onyx Implant System (K262067) by SI-BONE, Inc. was cleared on 2026-09-23 after 93 days of review.
How does iFuse Granite Onyx Implant System (K262067): 510(k) cleared for SI-BONE, Inc. compare to other California FDAPulse records?
Its amount of 93 is below the median (33th percentile); smaller records often move faster and face less competition. It is 42 days old, still within a typical 45-day follow-up window. Its Predicate Speed & CAPA Advisory Opportunity Score of 36/100 is modest; treat it as background rather than a priority.
iFuse Granite Onyx Implant System (K262067) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| iFuse Granite Onyx Implant System (K262067) | CA | 2026-09-23 |
| 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 |
Related records
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- F.A.S.T Screw (K254280): 510(k) cleared for Steps Ortho
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