FDA 510(k)

LATERAL OFFSET PROTRACT PRESS FIT HIP STEM

K-Number: K010282 · 2001-02-09

Decision Date2001-02-09

Product CodeLPH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

LATERAL OFFSET 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 2001-02-09 under 510(k) number K010282. 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 LATERAL OFFSET PROTRACT PRESS FIT HIP STEM?

LATERAL OFFSET PROTRACT PRESS FIT HIP STEM is a medical device that received FDA 510(k) clearance on 2001-02-09. The listed applicant is Stelkast Company. The 510(k) number is K010282.

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

LATERAL OFFSET PROTRACT PRESS FIT HIP STEM received FDA 510(k) clearance on 2001-02-09, under 510(k) number K010282.

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

The FDA product code for LATERAL OFFSET 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)

K261453G7® Acetabular SystemZimmer Biomet K253630Mpact 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 Orthopaedics K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi CoatingNextstep Arthopedix, LLC K251270Taperloc® 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.