Arthrex Spine Compression FT Screw (K262618): 510(k) cleared for Arthrex, Inc.
Arthrex Spine Compression FT Screw (K262618): 510(k) cleared for Arthrex, Inc. (Florida): 510(k) cleared for Arthrex, Inc. Its amount of 58 is below the median of 138 (15th 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: 58 · 15th percentile of 414 FDAPulse records · 0.4x the median
Free preview: all 14 published fields of this record are shown below. Locked: 15 related FL FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K262618 |
| Device | Arthrex Spine Compression FT Screw |
| Applicant | Arthrex, Inc. |
| Specialty / panel | Other |
| Product code | MRW |
| Device class | U |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-07-28 |
| Decision date | 2026-09-24 |
| Review time (days) | 58 |
| Third-party review | No |
| Applicant location | Naples, FL, US |
| amount percentile | 15th of 414 (median 138, 0.4x median) |
| Peer records CSV (16 FL records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 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: 2026-09-24
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
Top FDAPulse records (FL first): Multiple therapy aesthetic treatment device (BHS 202 UNYQUE) · Hemotag Analysis Software (HAS) (K252736) · Durashield Device Kit (K252995) · epi-ConneKt Wound Matrix (K260530) · BellaTek Bars (K260940) · 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: Arthrex Spine Compression FT Screw (K262618): 510(k) cleared for Arthrex, Inc. and 16 Florida peers
- Florida FDAPulse records like this one: 16
- Arthrex Spine Compression FT Screw (K262618): 510(k) cleared for Arthrex, Inc.'s amount: 15th percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Florida peer: $3,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
36 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 58-day review: this device is a strong predicate for similar products.
- Posted 42 days ago.
What is the FDAPulse record for Arthrex Spine Compression FT Screw (K262618): 510(k) cleared for Arthrex, Inc. in Florida?
Arthrex Spine Compression FT Screw (K262618) by Arthrex, Inc. was cleared on 2026-09-24 after 58 days of review.
How does Arthrex Spine Compression FT Screw (K262618): 510(k) cleared for Arthrex, Inc. compare to other Florida FDAPulse records?
Its amount of 58 is below the median (15th 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.
Arthrex Spine Compression FT Screw (K262618) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Arthrex Spine Compression FT Screw (K262618) | FL | 2026-09-24 |
| Needle Stimulator (SDZ-IIB, SDZ-IIC, SDZ-III, SDZ-V) (K260230) | CN | 2026-10-22 |
| STA® - Liquid Anti-Xa (K260214) | NJ | 2026-09-24 |
| BD OneFlow LST; BD OneFlow B-CLPD T1; BD FACSLyric Flow Cytometer, 8-color [4-2-2], 10-color [4-3-3], 12-color (4-3-5) (K260215) | CA | 2026-10-20 |
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- BD OneFlow LST; BD OneFlow B-CLPD T1; BD FACSLyric Flow Cytometer, 8-color [4-2-2], 10-color [4-3-3], 12-color (4-3-5) (K260215): 510(k) cleared for Bd Biosciences
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