Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Medtronic Total Hip Arthroplasty System

K-Number: K183129 · 2019-07-26

ApplicantMedtronic Advanced Energy
Decision Date2019-07-26
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Medtronic Total Hip Arthroplasty System is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Advanced Energy. It received FDA 510(k) clearance on 2019-07-26 under 510(k) number K183129. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Medtronic Total Hip Arthroplasty System?

Medtronic Total Hip Arthroplasty System is a medical device that received FDA 510(k) clearance on 2019-07-26. The listed applicant is Medtronic Advanced Energy. The 510(k) number is K183129.

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

Medtronic Total Hip Arthroplasty System received FDA 510(k) clearance on 2019-07-26, under 510(k) number K183129.

Who is the listed applicant for Medtronic Total Hip Arthroplasty System?

The FDA 510(k) record lists Medtronic Advanced Energy as the applicant. This does not by itself establish the device manufacturer.

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

The FDA product code for Medtronic Total Hip Arthroplasty System is LPH.

Other records listing Medtronic Advanced Energy 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.

K181257PlasmaBlade X 3.0S, PlasmaBlade X 4.0K170381Minimally Invasive Sealer (MIS) Flex, Minimally Invasive Sealer (MIS) Flex MiniK170610PlasmaBlade TK170296CoreCath 2.7SK152703PlasmaBlade TnA Tonsil and Adenoid Dissection Device

Related Devices (Code: LPH)

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.

K254043TRIVANCE™ Hip StemGlobus Medical, Inc.K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert; Trident® Crossfire® 0° Polyethylene Insert; Trident ® Crossfire ® 10° Polyethylene Insert;System 12 Crossfire® 10° Insert; Trident® 0° Constrained Acetabular Insert; Trident® Constrained Acetabular Liner;Trident® All Poly Constrained Acetabular Insert; Crossfire® Eccentric Insert 10°; Artisan® Bone Plug;UHR® Universal Head Bipolar ComponentHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi CoatingNextstep Arthopedix, LLCK251270Taperloc® Complete Hip StemBiomet, Inc.K252623G7® Revision Acetabular SystemZimmer, Inc.K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.

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.

↑