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FDA 510(k)

Newclip Patient-matched instrumentation non sterile PSI

K-Number: K250767 · 2025-10-01

ApplicantNewclip Technics
Decision Date2025-10-01
Product CodePBF
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Newclip Patient-matched instrumentation non sterile PSI is the device name listed in this FDA 510(k) record. The listed applicant is Newclip Technics. It received FDA 510(k) clearance on 2025-10-01 under 510(k) number K250767. The device is classified under product code PBF. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Newclip Patient-matched instrumentation non sterile PSI?

Newclip Patient-matched instrumentation non sterile PSI is a medical device that received FDA 510(k) clearance on 2025-10-01. The listed applicant is Newclip Technics. The 510(k) number is K250767.

When did Newclip Patient-matched instrumentation non sterile PSI receive FDA 510(k) clearance?

Newclip Patient-matched instrumentation non sterile PSI received FDA 510(k) clearance on 2025-10-01, under 510(k) number K250767.

Who is the listed applicant for Newclip Patient-matched instrumentation non sterile PSI?

The FDA 510(k) record lists Newclip Technics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Newclip Patient-matched instrumentation non sterile PSI?

The FDA product code for Newclip Patient-matched instrumentation non sterile PSI is PBF.

Other records listing Newclip Technics as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261511Xpert AnkleK261191Alians Elbow SK261038Xpert PFPK253906Xpert HandK250155Xpert KneeK243912Newclip Patient-matched instrumentation non sterile PSI

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Related Devices (Code: PBF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252064MedCAD® AccuStride™ SystemMedcadK250711VSP Orthopedics System3D Systems, Inc.K242603MyPAO SA guidesMedacta International S.A.K251709MedCAD® AccuStride™ SystemMedcadK250394Fine TTO™Bodycad Laboratories, Inc.K250921CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.

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.

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