CYPRESS MEDICAL BONE SCREW & PLATES— 510(k) K894719

Name: FDA 510(k) clearance K894719
Creator: U.S. Food and Drug Administration
Published: 1989-10-20

Substantially Equivalent

Cypress Medical Mfg., Inc.

FDA 510(k) clearance K894719 for CYPRESS MEDICAL BONE SCREW & PLATES, Substantially Equivalent on 1989-10-20. Applicant: Cypress Medical Mfg., Inc.. Device class: 2.

Clearance details

Applicant: Cypress Medical Mfg., Inc.
Product code: Code HWC
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 1989-07-24
Decision date: 1989-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palm Desert, CA, US

Download summary PDF View on FDA.gov ↗

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K894830 — CYPRESS CANNULATED BONE SCREW1989-08-30

Adverse events under product code HWC

product code HWC

Death: 20
Injury: 15,910
Malfunction: 8,192
Other: 1
Total: 24,123

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.