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FDA 510(k)

CONSENSUS ACETABULAR SHELL SYSTEM

K-Number: K060635 · 2006-04-28

ApplicantHayes Medical, Inc.
Decision Date2006-04-28
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CONSENSUS ACETABULAR SHELL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Hayes Medical, Inc.. It received FDA 510(k) clearance on 2006-04-28 under 510(k) number K060635. 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 ACETABULAR SHELL SYSTEM?

CONSENSUS ACETABULAR SHELL SYSTEM is a medical device that received FDA 510(k) clearance on 2006-04-28. The listed applicant is Hayes Medical, Inc.. The 510(k) number is K060635.

When did CONSENSUS ACETABULAR SHELL SYSTEM receive FDA 510(k) clearance?

CONSENSUS ACETABULAR SHELL SYSTEM received FDA 510(k) clearance on 2006-04-28, under 510(k) number K060635.

Who is the listed applicant for CONSENSUS ACETABULAR SHELL SYSTEM?

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

What is the FDA product code for CONSENSUS ACETABULAR SHELL SYSTEM?

The FDA product code for CONSENSUS ACETABULAR SHELL SYSTEM is LPH.

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Other records listing Hayes Medical, Inc. 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.

K07006136MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERTK062383UNISYN HA PLASMA MODULAR HIPK030151CONSENSUS HIP SYSTEM, UNISYN HIP SYSTEMK030205CONSENSUS UNIPOLAR HEAD, COCRK021466CONSENSUS ACETABULAR INSERT, CROSS-LINKED POLYETHYLENEK020153CONSENSUS ACETABLAR SHELL, TI COATED

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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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