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FDA 510(k)

PIPELINE TOTAL HIP SYSTEM (LINE EXTENSION)

K-Number: K130353 · 2013-07-01

ApplicantPipeline Orthopedics
Decision Date2013-07-01
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PIPELINE TOTAL HIP SYSTEM (LINE EXTENSION) is the device name listed in this FDA 510(k) record. The listed applicant is Pipeline Orthopedics. It received FDA 510(k) clearance on 2013-07-01 under 510(k) number K130353. 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 PIPELINE TOTAL HIP SYSTEM (LINE EXTENSION)?

PIPELINE TOTAL HIP SYSTEM (LINE EXTENSION) is a medical device that received FDA 510(k) clearance on 2013-07-01. The listed applicant is Pipeline Orthopedics. The 510(k) number is K130353.

When did PIPELINE TOTAL HIP SYSTEM (LINE EXTENSION) receive FDA 510(k) clearance?

PIPELINE TOTAL HIP SYSTEM (LINE EXTENSION) received FDA 510(k) clearance on 2013-07-01, under 510(k) number K130353.

Who is the listed applicant for PIPELINE TOTAL HIP SYSTEM (LINE EXTENSION)?

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

What is the FDA product code for PIPELINE TOTAL HIP SYSTEM (LINE EXTENSION)?

The FDA product code for PIPELINE TOTAL HIP SYSTEM (LINE EXTENSION) is LPH.

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Other records listing Pipeline Orthopedics 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.

K131368NEO KNEE SYSTEMK132046PIPELINE KNEE SYSTEMK131237PIPELINE TOTAL HIP SYSTEMK123692PIPELINE KNEE SYSTEMK122500NEO PS KNEE SYSTEMK120313NEO CR KNEE SYSTEM

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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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