FDA 510(k)

Xpert Hand

K-Number: K253906 · 2026-03-11

Decision Date2026-03-11

Product CodeHRS

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Xpert Hand is a medical device manufactured by Newclip Technics. It received FDA 510(k) clearance on 2026-03-11 under approval number K253906. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Xpert Hand?

Xpert Hand is a medical device that received FDA 510(k) clearance on 2026-03-11. It is manufactured by Newclip Technics. The 510(k) number is K253906.

When was Xpert Hand approved by the FDA?

Xpert Hand received FDA 510(k) clearance on 2026-03-11, under approval number K253906.

What company makes Xpert Hand?

Xpert Hand is manufactured by Newclip Technics.

What is the FDA product code for Xpert Hand?

The FDA product code for Xpert Hand is HRS.

Other Devices by Newclip Technics

K161448Footmotion Plating System K152289Alians Elbow Locking Plating System K160617Large Screws Range K172596Large Screws Range K171510Footmotion Plating System K170843Alians Fragment Specific

View all 23 devices →

Related Devices (Code: HRS)

K163086VLP MINI-MOD 2.0mm Column PlatesSmith & Nephew, Inc. K162829Medline UNITE® Ankle Fracture Plating SystemMedline Industries, Inc. K162974Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation K163007Biomet Microfixation SternaLock 360 Sternal Closure SystemBiomet Microfixation K161696aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5Aap Implantate AG K161747LOQTEQ® VA Distal Tibia Plate System: LOQTEQ® VA Distal Medial Tibia Plate 3.5; LOQTEQ® VA Distal Anterolateral Tibia Plate 3.5; LOQTEQ® VA Distal Fibula Plate 2.7/3.5Aap Implantate AG

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.