TOWNLEY TOTAL ELBOW SYSTEM— 510(k) K955916

Name: FDA 510(k) clearance K955916
Creator: U.S. Food and Drug Administration
Published: 1996-08-08

Substantially Equivalent

Biologically Oriented Prostheses

FDA 510(k) clearance K955916 for TOWNLEY TOTAL ELBOW SYSTEM, Substantially Equivalent on 1996-08-08. Applicant: Biologically Oriented Prostheses. Device class: 2.

Clearance details

Applicant: Biologically Oriented Prostheses
Product code: Code JDC
Device class: Class 2
Regulation: 21 CFR 888.3150
Advisory panel: Orthopedic
Date received: 1995-12-29
Decision date: 1996-08-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Port Huron, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JDC

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K153398 — Comprehensive SRS/Nexel Elbow2016-02-03
K150501 — Zimmer Nexel Total Elbow Ulnar Cement Diverter2015-04-23
K123862 — ZIMMER NEXEL TOTAL ELBOW2013-03-12

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K964472 — RIOPRO COBALT TRAPEZIOMETARCARPAL RESURFACING COMPONENT1997-02-03
K962769 — HORIZON HIP SYSTEM1996-10-03
K954768 — BIOPRO HEMI-ENDO MODULAR CERAMIC HEAD1996-01-18

Adverse events under product code JDC

product code JDC

Injury: 1,050
Total: 1,050

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.