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FDA 510(k)

ACTIVELOCK MODULAR FEMORAL HIP SYSTEM

K-Number: K980020 · 1998-04-03

ApplicantMetagen, LLC
Decision Date1998-04-03
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

ACTIVELOCK MODULAR FEMORAL HIP SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Metagen, LLC. It received FDA 510(k) clearance on 1998-04-03 under 510(k) number K980020. 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 ACTIVELOCK MODULAR FEMORAL HIP SYSTEM?

ACTIVELOCK MODULAR FEMORAL HIP SYSTEM is a medical device that received FDA 510(k) clearance on 1998-04-03. The listed applicant is Metagen, LLC. The 510(k) number is K980020.

When did ACTIVELOCK MODULAR FEMORAL HIP SYSTEM receive FDA 510(k) clearance?

ACTIVELOCK MODULAR FEMORAL HIP SYSTEM received FDA 510(k) clearance on 1998-04-03, under 510(k) number K980020.

Who is the listed applicant for ACTIVELOCK MODULAR FEMORAL HIP SYSTEM?

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

What is the FDA product code for ACTIVELOCK MODULAR FEMORAL HIP SYSTEM?

The FDA product code for ACTIVELOCK MODULAR FEMORAL HIP SYSTEM is LPH.

Related Clinical Trials

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Other records listing Metagen, LLC 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.

K983976METAGEN ACTIVELOCK WIRE CERCLAGE SYSTEMK980609SEGMENTAL DEFECT REPLACEMENT SYSTEMK964003METAGEN ALL POLY ACETABULAR CUP SYSTEMK963700METAGEN HIGH TIBIAL OSTEOTOMY 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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