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FDA 510(k)

Prime Acetabular Cup System

K-Number: K180798 · 2018-07-09

ApplicantMicroport Orthopedics, Inc.
Decision Date2018-07-09
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Prime Acetabular Cup System is the device name listed in this FDA 510(k) record. The listed applicant is Microport Orthopedics, Inc.. It received FDA 510(k) clearance on 2018-07-09 under 510(k) number K180798. 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 Prime Acetabular Cup System?

Prime Acetabular Cup System is a medical device that received FDA 510(k) clearance on 2018-07-09. The listed applicant is Microport Orthopedics, Inc.. The 510(k) number is K180798.

When did Prime Acetabular Cup System receive FDA 510(k) clearance?

Prime Acetabular Cup System received FDA 510(k) clearance on 2018-07-09, under 510(k) number K180798.

Who is the listed applicant for Prime Acetabular Cup System?

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

What is the FDA product code for Prime Acetabular Cup System?

The FDA product code for Prime Acetabular Cup System is LPH.

Other records listing Microport Orthopedics, Inc. as applicant

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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.

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