FDA 510(k)

Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology MR Labeling

K-Number: K182678 · 2019-05-31

Decision Date2019-05-31

Product CodeLPH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology MR Labeling is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer, Inc.. It received FDA 510(k) clearance on 2019-05-31 under 510(k) number K182678. 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 Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology MR Labeling?

Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology MR Labeling is a medical device that received FDA 510(k) clearance on 2019-05-31. The listed applicant is Zimmer, Inc.. The 510(k) number is K182678.

When did Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology MR Labeling receive FDA 510(k) clearance?

Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology MR Labeling received FDA 510(k) clearance on 2019-05-31, under 510(k) number K182678.

Who is the listed applicant for Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology MR Labeling?

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

What is the FDA product code for Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology MR Labeling?

The FDA product code for Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology MR Labeling is LPH.

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Other records listing Zimmer, Inc. as applicant

PMA P060037Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing K261683Augment Off-Axis Instrument System K260831Z1 Hip System K251840Zimmer® Persona® Personalized Knee System K260182Avenir® Müller Stem; Avenir Complete™ Hip System K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)

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Related Devices (Code: LPH)

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 Orthopaedics K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi CoatingNextstep Arthopedix, LLC K251270Taperloc® 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.