Xpert Hand— 510(k) K253906

Name: FDA 510(k) clearance K253906
Creator: U.S. Food and Drug Administration
Published: 2026-03-11

Substantially Equivalent

Newclip Technics

FDA 510(k) clearance K253906 for Xpert Hand, Substantially Equivalent on 2026-03-11. Applicant: Newclip Technics. Device class: 2.

Summary

Newclip Technics' Xpert Hand is filed under HRS, bone fixation plates. The record doesn't list plates or sizes.

Class II, 21 CFR 888.3030. Orthopedic is both the classification panel and the review panel. It was a Traditional 510(k).

Newclip Technics filed from Haute-Goulaine, France. The decision came 96 calendar days after receipt (December 5, 2025 to March 11, 2026).

Clearance details

Applicant: Newclip Technics
Product code: Product code HRS
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2025-12-05
Decision date: 2026-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Haute-Goulaine, FR

Download summary PDF View on FDA.gov ↗

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More clearances from Newclip Technics

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K262649 — Alians Forearm2026-09-28
K261511 — Xpert Ankle2026-07-28
K261191 — Alians Elbow S2026-07-08
K261038 — Xpert PFP2026-05-29
K250767 — Newclip Patient-matched instrumentation non sterile PSI2025-10-01

Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.