FDA 510(k)

KEYSTONE HIP SYSTEM CALCAR REPLACEMENT BODY AND BUILD UP

K-Number: K020170 · 2002-02-11

Decision Date2002-02-11

Product CodeLPH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

KEYSTONE HIP SYSTEM CALCAR REPLACEMENT BODY AND BUILD UP is the device name listed in this FDA 510(k) record. The listed applicant is Encore Orthopedics, Inc.. It received FDA 510(k) clearance on 2002-02-11 under 510(k) number K020170. 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 KEYSTONE HIP SYSTEM CALCAR REPLACEMENT BODY AND BUILD UP?

KEYSTONE HIP SYSTEM CALCAR REPLACEMENT BODY AND BUILD UP is a medical device that received FDA 510(k) clearance on 2002-02-11. The listed applicant is Encore Orthopedics, Inc.. The 510(k) number is K020170.

When did KEYSTONE HIP SYSTEM CALCAR REPLACEMENT BODY AND BUILD UP receive FDA 510(k) clearance?

KEYSTONE HIP SYSTEM CALCAR REPLACEMENT BODY AND BUILD UP received FDA 510(k) clearance on 2002-02-11, under 510(k) number K020170.

Who is the listed applicant for KEYSTONE HIP SYSTEM CALCAR REPLACEMENT BODY AND BUILD UP?

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

What is the FDA product code for KEYSTONE HIP SYSTEM CALCAR REPLACEMENT BODY AND BUILD UP?

The FDA product code for KEYSTONE HIP SYSTEM CALCAR REPLACEMENT BODY AND BUILD UP is LPH.

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Other records listing Encore Orthopedics, Inc. 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.