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FDA 510(k)

REPLICA(TM) TOTAL HIP SYSTEM

K-Number: K926156 · 1994-03-09

ApplicantOsteo Technology, Inc.
Decision Date1994-03-09
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

REPLICA(TM) TOTAL HIP SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Osteo Technology, Inc.. It received FDA 510(k) clearance on 1994-03-09 under 510(k) number K926156. 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(TM) TOTAL HIP SYSTEM?

REPLICA(TM) TOTAL HIP SYSTEM is a medical device that received FDA 510(k) clearance on 1994-03-09. The listed applicant is Osteo Technology, Inc.. The 510(k) number is K926156.

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

REPLICA(TM) TOTAL HIP SYSTEM received FDA 510(k) clearance on 1994-03-09, under 510(k) number K926156.

Who is the listed applicant for REPLICA(TM) TOTAL HIP SYSTEM?

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

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

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

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Other records listing Osteo Technology, 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.

K922859ANATOMICAL TYPE KNEE SYSTEMK922869TOTAL CONDYLAT TYPE KNEE SYSTEMK925447OTI ORTHOPEDIC WIRE SYSTEMK926213MODIFIED ZICKEL INTRAMEDULLARY ROD SYSTEMK922861BIOMETRIC SCREW FIXATION CUPK922870THREE SPIKE 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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