DRILL BIT— 510(k) K841629

Name: FDA 510(k) clearance K841629
Creator: U.S. Food and Drug Administration
Published: 1984-08-27

Substantially Equivalent

Plastafil, Inc.

FDA 510(k) clearance K841629 for DRILL BIT, Substantially Equivalent on 1984-08-27. Applicant: Plastafil, Inc.. Device class: 1.

Clearance details

Applicant: Plastafil, Inc.
Product code: Code HTW
Device class: Class 1
Regulation: 21 CFR 888.4540
Advisory panel: Orthopedic
Date received: 1984-04-19
Decision date: 1984-08-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K942906 — AGEE-WRISTJACK PRE-DRILL KIT1994-12-22
K930339 — REAMER BIT1993-08-06
K915692 — CANNULATED DRILL BIT1992-01-16
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Adverse events under product code HTW

product code HTW

Injury: 882
Malfunction: 8,544
Other: 3
Total: 9,429

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.