Product code HXX— Orthopedic

FDA has cleared 4 devices under product code HXX between 1986 and 1990, filed by 4 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

• 19901 clearance
• 19872 clearances
• 19861 clearance

• W. L. Gore & Associates, Inc.1 clearance
• Med-Tool, Inc.1 clearance
• Dalton Technology, Inc.1 clearance
• Buckman Co., Inc.1 clearance

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 →

• K901166 — DALTON TECHNOLOGY FLEXIBLE SCREWDRIVERDalton Technology, Inc.·1990-06-13
• K873066 — ACROMED SCREW DRIVERBuckman Co., Inc.·1987-09-02
• K872389 — PRECISION SCREW DRIVER SETMed-Tool, Inc.·1987-07-15
• K862689 — 2.5MM HEX DRIVER/CURVE PASSER/BONE PUNCH/RASPW. L. Gore & Associates, Inc.·1986-09-02