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FDA 510(k)

ZMR HIP SYSTEM-POROUS REVISION

K-Number: K994286 · 2000-03-10

ApplicantZimmer, Inc.
Decision Date2000-03-10
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ZMR HIP SYSTEM-POROUS REVISION is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer, Inc.. It received FDA 510(k) clearance on 2000-03-10 under 510(k) number K994286. 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 ZMR HIP SYSTEM-POROUS REVISION?

ZMR HIP SYSTEM-POROUS REVISION is a medical device that received FDA 510(k) clearance on 2000-03-10. The listed applicant is Zimmer, Inc.. The 510(k) number is K994286.

When did ZMR HIP SYSTEM-POROUS REVISION receive FDA 510(k) clearance?

ZMR HIP SYSTEM-POROUS REVISION received FDA 510(k) clearance on 2000-03-10, under 510(k) number K994286.

Who is the listed applicant for ZMR HIP SYSTEM-POROUS REVISION?

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 ZMR HIP SYSTEM-POROUS REVISION?

The FDA product code for ZMR HIP SYSTEM-POROUS REVISION is LPH.

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Other records listing Zimmer, Inc. as applicant

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K262955OsseoFit Stemless Shoulder SystemK260831Z1 Hip SystemK261683Augment Off-Axis Instrument SystemK251840Zimmer® Persona® Personalized Knee SystemK260182Avenir® Müller Stem; Avenir Complete™ Hip SystemK253592Zimmer 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)

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.

K261453G7® Acetabular SystemZimmer BiometK253630Mpact 3D Metal FoamMedacta International S.A.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.

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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