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FDA 510(k)

FANNING-PAPPAS MODULAR KNEE BEARING

K-Number: K081400 · 2009-02-20

ApplicantEndotec, Inc.
Decision Date2009-02-20
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FANNING-PAPPAS MODULAR KNEE BEARING is the device name listed in this FDA 510(k) record. The listed applicant is Endotec, Inc.. It received FDA 510(k) clearance on 2009-02-20 under 510(k) number K081400. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FANNING-PAPPAS MODULAR KNEE BEARING?

FANNING-PAPPAS MODULAR KNEE BEARING is a medical device that received FDA 510(k) clearance on 2009-02-20. The listed applicant is Endotec, Inc.. The 510(k) number is K081400.

When did FANNING-PAPPAS MODULAR KNEE BEARING receive FDA 510(k) clearance?

FANNING-PAPPAS MODULAR KNEE BEARING received FDA 510(k) clearance on 2009-02-20, under 510(k) number K081400.

Who is the listed applicant for FANNING-PAPPAS MODULAR KNEE BEARING?

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 FANNING-PAPPAS MODULAR KNEE BEARING?

The FDA product code for FANNING-PAPPAS MODULAR KNEE BEARING is JWH.

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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.

K012702BUECHEL-PAPPAS (B-P) FIXED BEARING NEW JERSEY (NJ) TOTAL KNEE, MODEL 1K992394BUECHEL-PAPPAS HUMERAL HEAD RESURFACING COMPONENTK982418BUECHEL-PAPPAS MODULAR SALVAGE STEMK963101B-P HEMISPHERICAL ACETABULAR COMPONENTK963100TRONZO ACETABULAR FIXATION COMPONENT (1 99-02-00XX (ACE. FIXATION CUP) XX=OD OF ACE. CUPK960425BUECHEL-PAPPAS POLYETHLENE ACETABULAR COMPONENT(01-42-YYXX & 01-43-YYXX

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Related Devices (Code: JWH)

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.

K262057GMK ExtensionMedacta International SAK260063GSPE SpacerThe General Hospital Corporation, d/b/a MassachusettsK262293EVOLUTION MPX™ Total Knee SystemSuzhou Microport Orthorecon Co., Ltd.K262341b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem ExtensionsB-One Ortho, Corp.K262130ATTUNE Revision Knee SystemDepuy Orthopaedics, Inc.K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd.

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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