Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

BEUCHEL-PAPPAS GLENOID COMPONENT

K-Number: K904879 · 1991-01-28

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

Device Summary

BEUCHEL-PAPPAS GLENOID 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 K904879. 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 BEUCHEL-PAPPAS GLENOID COMPONENT?

BEUCHEL-PAPPAS GLENOID 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 K904879.

When did BEUCHEL-PAPPAS GLENOID COMPONENT receive FDA 510(k) clearance?

BEUCHEL-PAPPAS GLENOID COMPONENT received FDA 510(k) clearance on 1991-01-28, under 510(k) number K904879.

Who is the listed applicant for BEUCHEL-PAPPAS GLENOID 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 BEUCHEL-PAPPAS GLENOID COMPONENT?

The FDA product code for BEUCHEL-PAPPAS GLENOID COMPONENT is KWS.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

↑