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FDA 510(k)

BUECHEL-PAPPAS MODULAR SALVAGE STEM

K-Number: K982418 · 1999-04-29

ApplicantEndotec, Inc.
Decision Date1999-04-29
Product CodeMJT
DecisionSubstantially Equivalent

Device Summary

BUECHEL-PAPPAS MODULAR SALVAGE STEM is the device name listed in this FDA 510(k) record. The listed applicant is Endotec, Inc.. It received FDA 510(k) clearance on 1999-04-29 under 510(k) number K982418. The device is classified under product code MJT. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BUECHEL-PAPPAS MODULAR SALVAGE STEM?

BUECHEL-PAPPAS MODULAR SALVAGE STEM is a medical device that received FDA 510(k) clearance on 1999-04-29. The listed applicant is Endotec, Inc.. The 510(k) number is K982418.

When did BUECHEL-PAPPAS MODULAR SALVAGE STEM receive FDA 510(k) clearance?

BUECHEL-PAPPAS MODULAR SALVAGE STEM received FDA 510(k) clearance on 1999-04-29, under 510(k) number K982418.

Who is the listed applicant for BUECHEL-PAPPAS MODULAR SALVAGE STEM?

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 MODULAR SALVAGE STEM?

The FDA product code for BUECHEL-PAPPAS MODULAR SALVAGE STEM is MJT.

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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 COMPONENTK963101B-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: MJT)

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.

K990712OSTEONICS SOLAR SHOULDER BIPOLAR SYSTEMHowmedica Osteonics Corp.K960363BIPOLAR SHOULDER PROSTHESIS-SHELL(RD-113130/33, BIANGULAR MODULAR HEAD(RD-113101/41/42,BIOMODULAR MODULAR HEAD(RD-113143Biomet, 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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