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FDA 510(k)

REPLICA TOTAL HIP SYSTEM

K-Number: K951741 · 1995-08-07

ApplicantOsteo-Technology Intl., Inc.
Decision Date1995-08-07
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

REPLICA TOTAL HIP SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Osteo-Technology Intl., Inc.. It received FDA 510(k) clearance on 1995-08-07 under 510(k) number K951741. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the REPLICA TOTAL HIP SYSTEM?

REPLICA TOTAL HIP SYSTEM is a medical device that received FDA 510(k) clearance on 1995-08-07. The listed applicant is Osteo-Technology Intl., Inc.. The 510(k) number is K951741.

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

REPLICA TOTAL HIP SYSTEM received FDA 510(k) clearance on 1995-08-07, under 510(k) number K951741.

Who is the listed applicant for REPLICA TOTAL HIP SYSTEM?

The FDA 510(k) record lists Osteo-Technology Intl., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REPLICA TOTAL HIP SYSTEM?

The FDA product code for REPLICA TOTAL HIP SYSTEM is LPH.

Related Clinical Trials

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.

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Other records listing Osteo-Technology Intl., Inc. 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.

K935012BIOMETRIC TOTAL HIP SYSTEMK925571OTI EUROPEAN COMPRESSION SYSTEM

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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