Alians Forearm (K262649): 510(k) cleared for Newclip Technics
Alians Forearm (K262649): 510(k) cleared for Newclip Technics: 510(k) cleared for Newclip Technics. Its amount of 60 is below the median of 138 (18th percentile). Dated 37 days ago, it serves as a historical benchmark. Score 36/100. 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: 60 · 18th percentile of 414 FDAPulse records · 0.4x the median
Free preview: all 14 published fields of this record are shown below. Locked: 5 related FR FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K262649 |
| Device | Alians Forearm |
| Applicant | Newclip Technics |
| Specialty / panel | Orthopedic |
| Product code | HRS |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-07-30 |
| Decision date | 2026-09-28 |
| Review time (days) | 60 |
| Third-party review | No |
| Applicant location | Haute-Goulaine, FR |
| amount percentile | 18th of 414 (median 138, 0.4x median) |
| Peer records CSV (6 FR 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: 2026-09-28
- 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: Alians Forearm (K262649): 510(k) cleared for Newclip Technics and 6 FR peers
- FR FDAPulse records like this one: 6
- Alians Forearm (K262649): 510(k) cleared for Newclip Technics's amount: 18th percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every FR peer: $1,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
36 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 60-day review: this device is a strong predicate for similar products.
- Posted 37 days ago.
What is the FDAPulse record for Alians Forearm (K262649): 510(k) cleared for Newclip Technics?
Alians Forearm (K262649) by Newclip Technics was cleared on 2026-09-28 after 60 days of review.
How does Alians Forearm (K262649): 510(k) cleared for Newclip Technics compare to other FDAPulse records?
Its amount of 60 is below the median (18th percentile); smaller records often move faster and face less competition. It is 37 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.
Alians Forearm (K262649) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Alians Forearm (K262649) | FR | 2026-09-28 |
| 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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- DynaNail Helix® Fixation System (K260995): 510(k) cleared for MedShape, Inc.
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- Tempo Plating System (K263407): 510(k) cleared for Pace Surgical
Recent FDA 510(k) clearances FDA 510(k) clearances and recalls: Orthopedic devices
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