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FDA 510(k)

BUECHEL-PAPPAS HUMERAL STEM COMPONENT

K-Number: K904880 · 1991-01-28

ApplicantEndotec, Inc.
Decision Date1991-01-28
Product CodeKWS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BUECHEL-PAPPAS HUMERAL STEM 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 1991-01-28 under 510(k) number K904880. The device is classified under product code KWS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BUECHEL-PAPPAS HUMERAL STEM COMPONENT?

BUECHEL-PAPPAS HUMERAL STEM COMPONENT is a medical device that received FDA 510(k) clearance on 1991-01-28. The listed applicant is Endotec, Inc.. The 510(k) number is K904880.

When did BUECHEL-PAPPAS HUMERAL STEM COMPONENT receive FDA 510(k) clearance?

BUECHEL-PAPPAS HUMERAL STEM COMPONENT received FDA 510(k) clearance on 1991-01-28, under 510(k) number K904880.

Who is the listed applicant for BUECHEL-PAPPAS HUMERAL STEM 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 BUECHEL-PAPPAS HUMERAL STEM COMPONENT?

The FDA product code for BUECHEL-PAPPAS HUMERAL STEM COMPONENT is KWS.

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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

View all 15 devices →

Related Devices (Code: KWS)

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.

K260721Tornier Perform Advanced GlenoidTornier, Inc.K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.K241292MyShoulder Planner (5.3SSWPL)Medacta International S.A.K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem)Stryker Corporation (Tornier, 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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