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FDA 510(k)

MALUC™ Total Hip Arthroplasty System

K-Number: K162125 · 2017-05-10

ApplicantSurgtech, Inc.
Decision Date2017-05-10
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MALUC™ Total Hip Arthroplasty System is the device name listed in this FDA 510(k) record. The listed applicant is Surgtech, Inc.. It received FDA 510(k) clearance on 2017-05-10 under 510(k) number K162125. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MALUC™ Total Hip Arthroplasty System?

MALUC™ Total Hip Arthroplasty System is a medical device that received FDA 510(k) clearance on 2017-05-10. The listed applicant is Surgtech, Inc.. The 510(k) number is K162125.

When did MALUC™ Total Hip Arthroplasty System receive FDA 510(k) clearance?

MALUC™ Total Hip Arthroplasty System received FDA 510(k) clearance on 2017-05-10, under 510(k) number K162125.

Who is the listed applicant for MALUC™ Total Hip Arthroplasty System?

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

What is the FDA product code for MALUC™ Total Hip Arthroplasty System?

The FDA product code for MALUC™ Total Hip Arthroplasty System is JDI.

Other records listing Surgtech, 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.

K191192SurgTech GENOLL Total Knee SystemK173455SurgTech Bipolar Head SystemK163363SurgTech Thoracolumbosacral (TLS) Posterior Fixation SystemK161894SurgTech Trauma SystemK152200SurgTech Interbody System

Related Devices (Code: JDI)

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.

K253434OSSTM Orthopedic Salvage SystemBiomet, Inc.K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.K243571Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained LinersZimmer BiometK240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip StemsSmith & Nephew, Inc.K241716Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee ComponentHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics

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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