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FDA 510(k)

The Response Ortho Smart Fixator - Hexapod System

K-Number: K252625 · 2025-11-20

ApplicantResponse Ortho Solutions, LLC
Decision Date2025-11-20
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

The Response Ortho Smart Fixator - Hexapod System is the device name listed in this FDA 510(k) record. The listed applicant is Response Ortho Solutions, LLC. It received FDA 510(k) clearance on 2025-11-20 under 510(k) number K252625. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the The Response Ortho Smart Fixator - Hexapod System?

The Response Ortho Smart Fixator - Hexapod System is a medical device that received FDA 510(k) clearance on 2025-11-20. The listed applicant is Response Ortho Solutions, LLC. The 510(k) number is K252625.

When did The Response Ortho Smart Fixator - Hexapod System receive FDA 510(k) clearance?

The Response Ortho Smart Fixator - Hexapod System received FDA 510(k) clearance on 2025-11-20, under 510(k) number K252625.

Who is the listed applicant for The Response Ortho Smart Fixator - Hexapod System?

The FDA 510(k) record lists Response Ortho Solutions, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for The Response Ortho Smart Fixator - Hexapod System?

The FDA product code for The Response Ortho Smart Fixator - Hexapod System is KTT.

Other records listing Response Ortho Solutions, LLC 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.

K241769Response Ortho Metaphyseal Hinge Fixator System

Related Devices (Code: KTT)

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.

K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLCK260900DYNEX® External Fixation SystemsVilex, LLCK260112QuikFix External Fixator: Knee-Spanning PackStabiliz Orthopaedics, Inc.K253291Excelsior SystemBlue Ocean GlobalK253613Monkey Rings External Ring Fixation SystemParagon 28, Inc.K253202Hoffmann LRF SystemStryker GmbH

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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