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FDA 510(k)

HORIZON HIP SYSTEM

K-Number: K962769 · 1996-10-03

ApplicantBiologically Oriented Prostheses
Decision Date1996-10-03
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HORIZON HIP SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Biologically Oriented Prostheses. It received FDA 510(k) clearance on 1996-10-03 under 510(k) number K962769. 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 HORIZON HIP SYSTEM?

HORIZON HIP SYSTEM is a medical device that received FDA 510(k) clearance on 1996-10-03. The listed applicant is Biologically Oriented Prostheses. The 510(k) number is K962769.

When did HORIZON HIP SYSTEM receive FDA 510(k) clearance?

HORIZON HIP SYSTEM received FDA 510(k) clearance on 1996-10-03, under 510(k) number K962769.

Who is the listed applicant for HORIZON HIP SYSTEM?

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

What is the FDA product code for HORIZON HIP SYSTEM?

The FDA product code for HORIZON HIP SYSTEM is LPH.

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Other records listing Biologically Oriented Prostheses 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.

K002325WUJIN #3 TIBIAL NAILK992144BIOPRO RIMMED ACETABULAR COMPOMENTK964472RIOPRO COBALT TRAPEZIOMETARCARPAL RESURFACING COMPONENTK955916TOWNLEY TOTAL ELBOW SYSTEMK954768BIOPRO HEMI-ENDO MODULAR CERAMIC HEADK952731TOWNLEY ALL POLY ACETABULAR CUP

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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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