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FDA 510(k)

BICON-PLUS ACETABULAR COMPONENTS

K-Number: K992154 · 2000-04-06

ApplicantPlus Orthopedics
Decision Date2000-04-06
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BICON-PLUS ACETABULAR COMPONENTS is the device name listed in this FDA 510(k) record. The listed applicant is Plus Orthopedics. It received FDA 510(k) clearance on 2000-04-06 under 510(k) number K992154. 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 BICON-PLUS ACETABULAR COMPONENTS?

BICON-PLUS ACETABULAR COMPONENTS is a medical device that received FDA 510(k) clearance on 2000-04-06. The listed applicant is Plus Orthopedics. The 510(k) number is K992154.

When did BICON-PLUS ACETABULAR COMPONENTS receive FDA 510(k) clearance?

BICON-PLUS ACETABULAR COMPONENTS received FDA 510(k) clearance on 2000-04-06, under 510(k) number K992154.

Who is the listed applicant for BICON-PLUS ACETABULAR COMPONENTS?

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

What is the FDA product code for BICON-PLUS ACETABULAR COMPONENTS?

The FDA product code for BICON-PLUS ACETABULAR COMPONENTS is LPH.

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Other records listing Plus Orthopedics 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.

K032126PROMOS SHOULDERK033763MODIFICATION TO SLIM GLIDING NAIL SYSTEMK032709MODULAR PLUS HIP STEMK032548IP-XS COMPRESSION NAIL SYSTEMK032215VKS/TC-PLUS REVISION KNEEK032052UC-PLUS SOLUTION UNICONDYLAR KNEE

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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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