FDA 510(k)

B-P HEMISPHERICAL ACETABULAR COMPONENT

K-Number: K963101 · 1997-02-12

Decision Date1997-02-12

Product CodeLPH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

B-P HEMISPHERICAL ACETABULAR COMPONENT is the device name listed in this FDA 510(k) record. The listed applicant is Endotec, Inc.. It received FDA 510(k) clearance on 1997-02-12 under 510(k) number K963101. 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 B-P HEMISPHERICAL ACETABULAR COMPONENT?

B-P HEMISPHERICAL ACETABULAR COMPONENT is a medical device that received FDA 510(k) clearance on 1997-02-12. The listed applicant is Endotec, Inc.. The 510(k) number is K963101.

When did B-P HEMISPHERICAL ACETABULAR COMPONENT receive FDA 510(k) clearance?

B-P HEMISPHERICAL ACETABULAR COMPONENT received FDA 510(k) clearance on 1997-02-12, under 510(k) number K963101.

Who is the listed applicant for B-P HEMISPHERICAL ACETABULAR COMPONENT?

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

What is the FDA product code for B-P HEMISPHERICAL ACETABULAR COMPONENT?

The FDA product code for B-P HEMISPHERICAL ACETABULAR COMPONENT is LPH.

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Other records listing Endotec, Inc. as applicant

K081400FANNING-PAPPAS MODULAR KNEE BEARING K012702BUECHEL-PAPPAS (B-P) FIXED BEARING NEW JERSEY (NJ) TOTAL KNEE, MODEL 1 K992394BUECHEL-PAPPAS HUMERAL HEAD RESURFACING COMPONENT K982418BUECHEL-PAPPAS MODULAR SALVAGE STEM K963100TRONZO ACETABULAR FIXATION COMPONENT (1 99-02-00XX (ACE. FIXATION CUP) XX=OD OF ACE. CUP K960425BUECHEL-PAPPAS POLYETHLENE ACETABULAR COMPONENT(01-42-YYXX & 01-43-YYXX

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Related Devices (Code: LPH)

K261453G7® Acetabular SystemZimmer Biomet K253630Mpact 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 Orthopaedics K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi CoatingNextstep Arthopedix, LLC K251270Taperloc® 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.