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FDA 510(k)

BUECHEL-PAPPAS POLYETHYLENE GLENOID COMPONENT (02-11-YYXX) NOTE:YY=ID & XX=OD

K-Number: K960424 · 1996-08-26

ApplicantEndotec, Inc.
Decision Date1996-08-26
Product CodeKWT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BUECHEL-PAPPAS POLYETHYLENE GLENOID COMPONENT (02-11-YYXX) NOTE:YY=ID & XX=OD is the device name listed in this FDA 510(k) record. The listed applicant is Endotec, Inc.. It received FDA 510(k) clearance on 1996-08-26 under 510(k) number K960424. The device is classified under product code KWT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BUECHEL-PAPPAS POLYETHYLENE GLENOID COMPONENT (02-11-YYXX) NOTE:YY=ID & XX=OD?

BUECHEL-PAPPAS POLYETHYLENE GLENOID COMPONENT (02-11-YYXX) NOTE:YY=ID & XX=OD is a medical device that received FDA 510(k) clearance on 1996-08-26. The listed applicant is Endotec, Inc.. The 510(k) number is K960424.

When did BUECHEL-PAPPAS POLYETHYLENE GLENOID COMPONENT (02-11-YYXX) NOTE:YY=ID & XX=OD receive FDA 510(k) clearance?

BUECHEL-PAPPAS POLYETHYLENE GLENOID COMPONENT (02-11-YYXX) NOTE:YY=ID & XX=OD received FDA 510(k) clearance on 1996-08-26, under 510(k) number K960424.

Who is the listed applicant for BUECHEL-PAPPAS POLYETHYLENE GLENOID COMPONENT (02-11-YYXX) NOTE:YY=ID & XX=OD?

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 BUECHEL-PAPPAS POLYETHYLENE GLENOID COMPONENT (02-11-YYXX) NOTE:YY=ID & XX=OD?

The FDA product code for BUECHEL-PAPPAS POLYETHYLENE GLENOID COMPONENT (02-11-YYXX) NOTE:YY=ID & XX=OD is KWT.

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Other records listing Endotec, 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.

K081400FANNING-PAPPAS MODULAR KNEE BEARINGK012702BUECHEL-PAPPAS (B-P) FIXED BEARING NEW JERSEY (NJ) TOTAL KNEE, MODEL 1K992394BUECHEL-PAPPAS HUMERAL HEAD RESURFACING COMPONENTK982418BUECHEL-PAPPAS MODULAR SALVAGE STEMK963100TRONZO ACETABULAR FIXATION COMPONENT (1 99-02-00XX (ACE. FIXATION CUP) XX=OD OF ACE. CUPK963101B-P HEMISPHERICAL ACETABULAR COMPONENT

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Related Devices (Code: KWT)

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.

K262173N22 Offset Humeral HeadShoulder Innovations, Inc.K250713Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder ImplantsExactech, Inc.K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbHK241817InSet Total Shoulder SystemShoulder Innovations, Inc.K231657AGILON® XO Shoulder Replacement SystemImplantcast GmbH

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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