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FDA 510(k)

PROTRACT PRESS FIT HIP STEM

K-Number: K003447 · 2000-12-15

ApplicantStelkast Company
Decision Date2000-12-15
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PROTRACT PRESS FIT HIP STEM is the device name listed in this FDA 510(k) record. The listed applicant is Stelkast Company. It received FDA 510(k) clearance on 2000-12-15 under 510(k) number K003447. 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 PROTRACT PRESS FIT HIP STEM?

PROTRACT PRESS FIT HIP STEM is a medical device that received FDA 510(k) clearance on 2000-12-15. The listed applicant is Stelkast Company. The 510(k) number is K003447.

When did PROTRACT PRESS FIT HIP STEM receive FDA 510(k) clearance?

PROTRACT PRESS FIT HIP STEM received FDA 510(k) clearance on 2000-12-15, under 510(k) number K003447.

Who is the listed applicant for PROTRACT PRESS FIT HIP STEM?

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

What is the FDA product code for PROTRACT PRESS FIT HIP STEM?

The FDA product code for PROTRACT PRESS FIT HIP STEM is LPH.

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Other records listing Stelkast Company 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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