STUART CD UNIVERSAL ROD CONNECTOR CLAMPS— 510(k) K894702

Name: FDA 510(k) clearance K894702
Creator: U.S. Food and Drug Administration
Published: 1989-10-11

Substantially Equivalent for Some Indications

Bio-Medical Prosthetics

FDA 510(k) clearance K894702 for STUART CD UNIVERSAL ROD CONNECTOR CLAMPS, Substantially Equivalent for Some Indications on 1989-10-11. Applicant: Bio-Medical Prosthetics. Device class: 2.

Clearance details

Applicant: Bio-Medical Prosthetics
Product code: Code KWP
Device class: Class 2
Regulation: 21 CFR 888.3050
Advisory panel: Orthopedic
Date received: 1989-07-27
Decision date: 1989-10-11
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Rockville, MD, US

Download summary PDF View on FDA.gov ↗

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K150254 — Streamline OCT Occipito-Cervico-Thoracic System2015-04-28

Adverse events under product code KWP

product code KWP

Death: 7
Injury: 1,539
Malfunction: 1,519
Total: 3,065

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.