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FDA 510(k)

HEMISPHERE MODULAR CUP SYSTEM

K-Number: K000321 · 2000-04-10

ApplicantOrtho Development Corp.
Decision Date2000-04-10
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HEMISPHERE MODULAR CUP SYSTEM 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 2000-04-10 under 510(k) number K000321. 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 HEMISPHERE MODULAR CUP SYSTEM?

HEMISPHERE MODULAR CUP SYSTEM is a medical device that received FDA 510(k) clearance on 2000-04-10. The listed applicant is Ortho Development Corp.. The 510(k) number is K000321.

When did HEMISPHERE MODULAR CUP SYSTEM receive FDA 510(k) clearance?

HEMISPHERE MODULAR CUP SYSTEM received FDA 510(k) clearance on 2000-04-10, under 510(k) number K000321.

Who is the listed applicant for HEMISPHERE MODULAR CUP SYSTEM?

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 HEMISPHERE MODULAR CUP SYSTEM?

The FDA product code for HEMISPHERE MODULAR CUP SYSTEM 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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