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FDA 510(k)

ESCALADE ACETABULAR CUP SYSTEM

K-Number: K103384 · 2011-03-16

ApplicantOrtho Development
Decision Date2011-03-16
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ESCALADE ACETABULAR CUP SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Development. It received FDA 510(k) clearance on 2011-03-16 under 510(k) number K103384. 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 ESCALADE ACETABULAR CUP SYSTEM?

ESCALADE ACETABULAR CUP SYSTEM is a medical device that received FDA 510(k) clearance on 2011-03-16. The listed applicant is Ortho Development. The 510(k) number is K103384.

When did ESCALADE ACETABULAR CUP SYSTEM receive FDA 510(k) clearance?

ESCALADE ACETABULAR CUP SYSTEM received FDA 510(k) clearance on 2011-03-16, under 510(k) number K103384.

Who is the listed applicant for ESCALADE ACETABULAR CUP SYSTEM?

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

What is the FDA product code for ESCALADE ACETABULAR CUP SYSTEM?

The FDA product code for ESCALADE ACETABULAR CUP SYSTEM is LPH.

Related Clinical Trials

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Other records listing Ortho Development as applicant

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.

K111965VUSION(R) OSK111936ORTHO DEVLOPMENT CERAMIC FEMORAL HEADK103837BALANCED KNEE SYSTEM REVISION OFFSET TIBIA

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

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

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