DALTON TECHNOLOGY FLEXIBLE SCREWDRIVER— 510(k) K901166

Name: FDA 510(k) clearance K901166
Creator: U.S. Food and Drug Administration
Published: 1990-06-13

Substantially Equivalent

Dalton Technology, Inc.

FDA 510(k) clearance K901166 for DALTON TECHNOLOGY FLEXIBLE SCREWDRIVER, Substantially Equivalent on 1990-06-13. Applicant: Dalton Technology, Inc.. Device class: 1.

Clearance details

Applicant: Dalton Technology, Inc.
Product code: Code HXX
Device class: Class 1
Regulation: 21 CFR 888.4540
Advisory panel: Orthopedic
Date received: 1990-03-13
Decision date: 1990-06-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Glendale, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HXX

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K873066 — ACROMED SCREW DRIVER1987-09-02
K872389 — PRECISION SCREW DRIVER SET1987-07-15
K862689 — 2.5MM HEX DRIVER/CURVE PASSER/BONE PUNCH/RASP1986-09-02

More clearances from Dalton Technology, Inc.

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K901165 — MODULAR FLEXIBLE DRILLING SYSTEM1990-06-13

Adverse events under product code HXX

product code HXX

Injury: 471
Malfunction: 10,945
Total: 11,416

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.