SURGICAL DRILL BITS— 510(k) K831712

Name: FDA 510(k) clearance K831712
Creator: U.S. Food and Drug Administration
Published: 1983-07-07

Substantially Equivalent

Medical Specialists IN Packaging

FDA 510(k) clearance K831712 for SURGICAL DRILL BITS, Substantially Equivalent on 1983-07-07. Applicant: Medical Specialists IN Packaging. Device class: 1.

Clearance details

Applicant: Medical Specialists IN Packaging
Product code: Code HTW
Device class: Class 1
Regulation: 21 CFR 888.4540
Advisory panel: Orthopedic
Date received: 1983-05-27
Decision date: 1983-07-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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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.