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FDA 510(k)

INFINTY DISTAL FEMORAL COMPONENT

K-Number: K973530 · 1997-10-16

ApplicantWrightmedicaltechnologyinc
Decision Date1997-10-16
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

INFINTY DISTAL FEMORAL COMPONENT is the device name listed in this FDA 510(k) record. The listed applicant is Wrightmedicaltechnologyinc. It received FDA 510(k) clearance on 1997-10-16 under 510(k) number K973530. 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 INFINTY DISTAL FEMORAL COMPONENT?

INFINTY DISTAL FEMORAL COMPONENT is a medical device that received FDA 510(k) clearance on 1997-10-16. The listed applicant is Wrightmedicaltechnologyinc. The 510(k) number is K973530.

When did INFINTY DISTAL FEMORAL COMPONENT receive FDA 510(k) clearance?

INFINTY DISTAL FEMORAL COMPONENT received FDA 510(k) clearance on 1997-10-16, under 510(k) number K973530.

Who is the listed applicant for INFINTY DISTAL FEMORAL COMPONENT?

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

What is the FDA product code for INFINTY DISTAL FEMORAL COMPONENT?

The FDA product code for INFINTY DISTAL FEMORAL COMPONENT 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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