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)

BUECHEL-PAPPAS EXTENDED COLLAR FEMORAL STEM PROSTH

K-Number: K905262 · 1993-05-19

ApplicantEndotec, Inc.
Decision Date1993-05-19
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

BUECHEL-PAPPAS EXTENDED COLLAR FEMORAL STEM PROSTH is the device name listed in this FDA 510(k) record. The listed applicant is Endotec, Inc.. It received FDA 510(k) clearance on 1993-05-19 under 510(k) number K905262. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the BUECHEL-PAPPAS EXTENDED COLLAR FEMORAL STEM PROSTH?

BUECHEL-PAPPAS EXTENDED COLLAR FEMORAL STEM PROSTH is a medical device that received FDA 510(k) clearance on 1993-05-19. The listed applicant is Endotec, Inc.. The 510(k) number is K905262.

When did BUECHEL-PAPPAS EXTENDED COLLAR FEMORAL STEM PROSTH receive FDA 510(k) clearance?

BUECHEL-PAPPAS EXTENDED COLLAR FEMORAL STEM PROSTH received FDA 510(k) clearance on 1993-05-19, under 510(k) number K905262.

Who is the listed applicant for BUECHEL-PAPPAS EXTENDED COLLAR FEMORAL STEM PROSTH?

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 EXTENDED COLLAR FEMORAL STEM PROSTH?

The FDA product code for BUECHEL-PAPPAS EXTENDED COLLAR FEMORAL STEM PROSTH is JDI.

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: JDI)

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.

K253515Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and AugmentsBiomet Orthopedics, Inc.K253434OSSTM Orthopedic Salvage SystemBiomet, Inc.K243571Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained LinersZimmer BiometK240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip StemsSmith & Nephew, Inc.K241716Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee ComponentHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics

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.

↑