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FDA 510(k)

CONSENSUS BIOLOX DELTA CERAMIC FEMORAL HEAD

K-Number: K110542 · 2011-04-01

ApplicantConsensus Orthopedics, Inc.
Decision Date2011-04-01
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CONSENSUS BIOLOX DELTA CERAMIC FEMORAL HEAD is the device name listed in this FDA 510(k) record. The listed applicant is Consensus Orthopedics, Inc.. It received FDA 510(k) clearance on 2011-04-01 under 510(k) number K110542. 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 CONSENSUS BIOLOX DELTA CERAMIC FEMORAL HEAD?

CONSENSUS BIOLOX DELTA CERAMIC FEMORAL HEAD is a medical device that received FDA 510(k) clearance on 2011-04-01. The listed applicant is Consensus Orthopedics, Inc.. The 510(k) number is K110542.

When did CONSENSUS BIOLOX DELTA CERAMIC FEMORAL HEAD receive FDA 510(k) clearance?

CONSENSUS BIOLOX DELTA CERAMIC FEMORAL HEAD received FDA 510(k) clearance on 2011-04-01, under 510(k) number K110542.

Who is the listed applicant for CONSENSUS BIOLOX DELTA CERAMIC FEMORAL HEAD?

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

What is the FDA product code for CONSENSUS BIOLOX DELTA CERAMIC FEMORAL HEAD?

The FDA product code for CONSENSUS BIOLOX DELTA CERAMIC FEMORAL HEAD is LPH.

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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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