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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 a medical device manufactured by Response Ortho Solutions, LLC. It received FDA 510(k) clearance on 2024-09-18 under approval 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. It is manufactured by Response Ortho Solutions, LLC. The 510(k) number is K241769.

When was Response Ortho Metaphyseal Hinge Fixator System approved by the FDA?

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

What company makes Response Ortho Metaphyseal Hinge Fixator System?

Response Ortho Metaphyseal Hinge Fixator System is manufactured by Response Ortho Solutions, LLC.

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.

Related Clinical Trials

NCT07608939 Postoperative Pain After Root Canal Treatment Using Different Root Canal Sealers NOT_YET_RECRUITING NCT07409545 Autonomic Nervous System Intrapartum Monitoring to Prevent Neonatal Adverse Outcomes NOT_YET_RECRUITING NCT05501873 Real World Data Collection in Subjects Treated With the FARAPULSE Pulsed Field Ablation System ACTIVE_NOT_RECRUITING NCT07561372 Adaptive Recruitment Curve Analysis Using Bayesian Modeling NOT_YET_RECRUITING NCT06868979 Optical Imaging in X-linked Disorders. RECRUITING NCT05535738 Using a Contact Dermatitis Model With Biologic Medications to Study Skin Inflammation ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026)

Other Devices by Response Ortho Solutions, LLC

K252625The Response Ortho Smart Fixator - Hexapod System

Related Devices (Code: KTT)

K160972Gexfix External FixationGexfix International Corp. K161753Hoffman LRF SystemStryker GmbH K161417DePuy Synthes MAXFRAME Multi-Axial Correction SystemSynthes USA, LLC K160830Integra External Fixation SystemAscension Orthopedics K153377Hoffmann LRF (Limb Reconstruction Frame) SystemStryker GmbH K151881X-Fix Line AdditionsVilex IN Tennessee, 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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