FDA 510(k)

ENCOMPASS 1017 AND 1217 EXTENDED PRESS-FIT HIP STEMS

K-Number: K053293 · 2006-02-16

Decision Date2006-02-16

Product CodeLPH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

ENCOMPASS 10*17 AND 12*17 EXTENDED PRESS-FIT HIP STEMS is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Development Corp.. It received FDA 510(k) clearance on 2006-02-16 under 510(k) number K053293. 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 ENCOMPASS 10*17 AND 12*17 EXTENDED PRESS-FIT HIP STEMS?

ENCOMPASS 10*17 AND 12*17 EXTENDED PRESS-FIT HIP STEMS is a medical device that received FDA 510(k) clearance on 2006-02-16. The listed applicant is Ortho Development Corp.. The 510(k) number is K053293.

When did ENCOMPASS 10*17 AND 12*17 EXTENDED PRESS-FIT HIP STEMS receive FDA 510(k) clearance?

ENCOMPASS 10*17 AND 12*17 EXTENDED PRESS-FIT HIP STEMS received FDA 510(k) clearance on 2006-02-16, under 510(k) number K053293.

Who is the listed applicant for ENCOMPASS 10*17 AND 12*17 EXTENDED PRESS-FIT HIP STEMS?

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

What is the FDA product code for ENCOMPASS 10*17 AND 12*17 EXTENDED PRESS-FIT HIP STEMS?

The FDA product code for ENCOMPASS 10*17 AND 12*17 EXTENDED PRESS-FIT HIP STEMS is LPH.

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Other records listing Ortho Development Corp. 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.