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FDA 510(k)

Fine TTO™

K-Number: K250394 · 2025-10-21

ApplicantBodycad Laboratories, Inc.
Decision Date2025-10-21
Product CodePBF
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Fine TTO™ is the device name listed in this FDA 510(k) record. The listed applicant is Bodycad Laboratories, Inc.. It received FDA 510(k) clearance on 2025-10-21 under 510(k) number K250394. 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 Fine TTO™?

Fine TTO™ is a medical device that received FDA 510(k) clearance on 2025-10-21. The listed applicant is Bodycad Laboratories, Inc.. The 510(k) number is K250394.

When did Fine TTO™ receive FDA 510(k) clearance?

Fine TTO™ received FDA 510(k) clearance on 2025-10-21, under 510(k) number K250394.

Who is the listed applicant for Fine TTO™?

The FDA 510(k) record lists Bodycad Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Fine TTO™?

The FDA product code for Fine TTO™ is PBF.

Other records listing Bodycad Laboratories, Inc. 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.

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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™ SystemMedcadK250767Newclip Patient-matched instrumentation non sterile PSINewclip TechnicsK250921CORIOGRAPH 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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