STRYKER SAGITTAL SAW ATTACHMENT— 510(k) K954483

Name: FDA 510(k) clearance K954483
Creator: U.S. Food and Drug Administration
Published: 1996-01-30

Substantially Equivalent

Stryker Instruments

FDA 510(k) clearance K954483 for STRYKER SAGITTAL SAW ATTACHMENT, Substantially Equivalent on 1996-01-30. Applicant: Stryker Instruments. Device class: 1.

Clearance details

Applicant: Stryker Instruments
Product code: Code GFA
Device class: Class 1
Regulation: 21 CFR 878.4820
Advisory panel: General, Plastic Surgery
Date received: 1995-09-27
Decision date: 1996-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kalamazoo, MI, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GFA

product code GFA

Death: 2
Injury: 140
Malfunction: 2,337
Total: 2,479

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.