GRAFT HARVESTING SAWBLADES— 510(k) K971978

Name: FDA 510(k) clearance K971978
Creator: U.S. Food and Drug Administration
Published: 1997-06-18

Substantially Equivalent

Wrightmedicaltechnologyinc

FDA 510(k) clearance K971978 for GRAFT HARVESTING SAWBLADES, Substantially Equivalent on 1997-06-18. Applicant: Wrightmedicaltechnologyinc. Device class: 1.

Clearance details

Applicant: Wrightmedicaltechnologyinc
Product code: Code GFA
Device class: Class 1
Regulation: 21 CFR 878.4820
Advisory panel: General, Plastic Surgery
Date received: 1997-05-29
Decision date: 1997-06-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arlington, TN, US

Download summary PDF View on FDA.gov ↗

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K954483 — STRYKER SAGITTAL SAW ATTACHMENT1996-01-30
K955229 — WRIGHT MEDICAL TECHNOLOGY SAWBLADES1996-01-18
K953012 — DISPOSABLE & REUSABLE SURGICAL CUTTING TOOLS1995-07-12
K950403 — SURGICAL SAW BLADES1995-02-21
K940501 — RE-SHARPENABLE SAW BLADES1994-06-28

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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.