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FDA 510(k)

Response Ortho Metaphyseal Hinge Fixator System

K-Number: K241769 · 2024-09-18

ApplicantResponse Ortho Solutions, LLC
Decision Date2024-09-18
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Response Ortho Metaphyseal Hinge Fixator 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 2024-09-18 under 510(k) number K241769. 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 Response Ortho Metaphyseal Hinge Fixator System?

Response Ortho Metaphyseal Hinge Fixator System is a medical device that received FDA 510(k) clearance on 2024-09-18. The listed applicant is Response Ortho Solutions, LLC. The 510(k) number is K241769.

When did Response Ortho Metaphyseal Hinge Fixator System receive FDA 510(k) clearance?

Response Ortho Metaphyseal Hinge Fixator System received FDA 510(k) clearance on 2024-09-18, under 510(k) number K241769.

Who is the listed applicant for Response Ortho Metaphyseal Hinge Fixator 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 Response Ortho Metaphyseal Hinge Fixator System?

The FDA product code for Response Ortho Metaphyseal Hinge Fixator 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.

K252625The Response Ortho Smart Fixator - Hexapod 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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