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FDA 510(k)

MODIFICATION TO TITANIUM TRI-LOCK HIPS STEM

K-Number: K010367 · 2001-03-09

ApplicantDePuy Orthopaedics, Inc.
Decision Date2001-03-09
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO TITANIUM TRI-LOCK HIPS STEM is the device name listed in this FDA 510(k) record. The listed applicant is DePuy Orthopaedics, Inc.. It received FDA 510(k) clearance on 2001-03-09 under 510(k) number K010367. 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 MODIFICATION TO TITANIUM TRI-LOCK HIPS STEM?

MODIFICATION TO TITANIUM TRI-LOCK HIPS STEM is a medical device that received FDA 510(k) clearance on 2001-03-09. The listed applicant is DePuy Orthopaedics, Inc.. The 510(k) number is K010367.

When did MODIFICATION TO TITANIUM TRI-LOCK HIPS STEM receive FDA 510(k) clearance?

MODIFICATION TO TITANIUM TRI-LOCK HIPS STEM received FDA 510(k) clearance on 2001-03-09, under 510(k) number K010367.

Who is the listed applicant for MODIFICATION TO TITANIUM TRI-LOCK HIPS STEM?

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

What is the FDA product code for MODIFICATION TO TITANIUM TRI-LOCK HIPS STEM?

The FDA product code for MODIFICATION TO TITANIUM TRI-LOCK HIPS STEM is LPH.

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Other records listing DePuy Orthopaedics, Inc. as applicant

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K262130ATTUNE Revision Knee SystemK252887DePuy ATTUNE™ Knee SystemK231503CUPTIMIZE™ AdvancedK213839DePuy Corail AMT Hip ProsthesisK210167DELTA XTEND Reverse Shoulder SystemK203167DePuy Corail AMT Hip Prosthesis

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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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