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FDA 510(k)

TRIDENT POROUS TITANIUM ACETABULAR COMPONENT WITH PERI-APATITE COATING

K-Number: K013475 · 2001-12-20

ApplicantHowmedica Osteonics Corp.
Decision Date2001-12-20
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TRIDENT POROUS TITANIUM ACETABULAR COMPONENT WITH PERI-APATITE COATING is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Osteonics Corp.. It received FDA 510(k) clearance on 2001-12-20 under 510(k) number K013475. 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 TRIDENT POROUS TITANIUM ACETABULAR COMPONENT WITH PERI-APATITE COATING?

TRIDENT POROUS TITANIUM ACETABULAR COMPONENT WITH PERI-APATITE COATING is a medical device that received FDA 510(k) clearance on 2001-12-20. The listed applicant is Howmedica Osteonics Corp.. The 510(k) number is K013475.

When did TRIDENT POROUS TITANIUM ACETABULAR COMPONENT WITH PERI-APATITE COATING receive FDA 510(k) clearance?

TRIDENT POROUS TITANIUM ACETABULAR COMPONENT WITH PERI-APATITE COATING received FDA 510(k) clearance on 2001-12-20, under 510(k) number K013475.

Who is the listed applicant for TRIDENT POROUS TITANIUM ACETABULAR COMPONENT WITH PERI-APATITE COATING?

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

What is the FDA product code for TRIDENT POROUS TITANIUM ACETABULAR COMPONENT WITH PERI-APATITE COATING?

The FDA product code for TRIDENT POROUS TITANIUM ACETABULAR COMPONENT WITH PERI-APATITE COATING is LPH.

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Other records listing Howmedica Osteonics Corp. as applicant

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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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