SABER-C System (K263049): 510(k) cleared for Elevation Spine
SABER-C System (K263049): 510(k) cleared for Elevation Spine (California): 510(k) cleared for Elevation Spine. Its amount of 23 is below the median of 138 (1st percentile). Dated 42 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: 23 · 1th percentile of 414 FDAPulse records · 0.2x 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 | K263049 |
| Device | SABER-C System |
| Applicant | Elevation Spine |
| Specialty / panel | Orthopedic |
| Product code | OVE |
| Device class | 2 |
| Clearance type | Special |
| Decision | Substantially Equivalent |
| Received | 2026-08-31 |
| Decision date | 2026-09-23 |
| Review time (days) | 23 |
| Third-party review | No |
| Applicant location | Monteray, CA, US |
| amount percentile | 1th of 414 (median 138, 0.2x median) |
| Peer records CSV (76 CA 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: 2026-09-23
- 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: SABER-C System (K263049): 510(k) cleared for Elevation Spine and 76 California peers
- California FDAPulse records like this one: 76
- SABER-C System (K263049): 510(k) cleared for Elevation Spine's amount: 1st 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)
41 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 23-day review: this device is a strong predicate for similar products.
- Special 510(k): a modification of an existing device.
- Posted 42 days ago.
What is the FDAPulse record for SABER-C System (K263049): 510(k) cleared for Elevation Spine in California?
SABER-C System (K263049) by Elevation Spine was cleared on 2026-09-23 after 23 days of review.
How does SABER-C System (K263049): 510(k) cleared for Elevation Spine compare to other California FDAPulse records?
Its amount of 23 is below the median (1th percentile); smaller records often move faster and face less competition. It is 42 days old, still within a typical 45-day follow-up window.
SABER-C System (K263049) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| SABER-C System (K263049) | 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
- TruVision Single-Use 1.9mm Arthroscopy System (K260156): 510(k) cleared for Nexus CMF, LLC
- Kentrospine Viktr-MIS® Pedicle screw system (K252139): 510(k) cleared for Rivarp Medical Pvt., Ltd.
- F.A.S.T Screw (K254280): 510(k) cleared for Steps Ortho
- The VEGA Cervical Screw System (K254260): 510(k) cleared for GS Medical Co., Ltd.
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