GSB ELBOW— 510(k) K901581

Name: FDA 510(k) clearance K901581
Creator: U.S. Food and Drug Administration
Published: 1990-10-22

Substantially Equivalent

Allo Pro Corp.

FDA 510(k) clearance K901581 for GSB ELBOW, Substantially Equivalent on 1990-10-22. Applicant: Allo Pro Corp.. Device class: 2.

Clearance details

Applicant: Allo Pro Corp.
Product code: Code JDC
Device class: Class 2
Regulation: 21 CFR 888.3150
Advisory panel: Orthopedic
Date received: 1990-04-04
Decision date: 1990-10-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clearwater, FL, US

Download summary PDF View on FDA.gov ↗

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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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K885049 — RS-CUP ACETABULAR PROSTHESIS1989-01-13

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.