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FDA 510(k)

Depuy Synthes Femoral Neck System

K-Number: K182154 · 2018-10-16

ApplicantSynthes (USA) Products, LLC
Decision Date2018-10-16
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Depuy Synthes Femoral Neck System is the device name listed in this FDA 510(k) record. The listed applicant is Synthes (USA) Products, LLC. It received FDA 510(k) clearance on 2018-10-16 under 510(k) number K182154. 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 Depuy Synthes Femoral Neck System?

Depuy Synthes Femoral Neck System is a medical device that received FDA 510(k) clearance on 2018-10-16. The listed applicant is Synthes (USA) Products, LLC. The 510(k) number is K182154.

When did Depuy Synthes Femoral Neck System receive FDA 510(k) clearance?

Depuy Synthes Femoral Neck System received FDA 510(k) clearance on 2018-10-16, under 510(k) number K182154.

Who is the listed applicant for Depuy Synthes Femoral Neck System?

The FDA 510(k) record lists Synthes (USA) Products, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Depuy Synthes Femoral Neck System?

The FDA product code for Depuy Synthes Femoral Neck System is KTT.

Related Clinical Trials

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.

NCT04462172A Prospective Multicenter Cohort Study About Internal Fixation Using FNS Versus MCS for Femoral Neck FractureCOMPLETED

Other records listing Synthes (USA) Products, 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.

K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemK212943SyntheCel Dura RepairK211313MAXFRAME Multi-Axial Correction System (aka MAXFRAME)K210408DePuy Synthes Variable Angle Locking Patella Plating SystemK210205DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating SystemK201346DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Screws for Medullary Nails, 5.0 mm

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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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