Product code HXK— Orthopedic

FDA has cleared 5 devices under product code HXK between 1978 and 1989, filed by 5 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.

• 19891 clearance
• 19871 clearance
• 19861 clearance
• 19801 clearance
• 19781 clearance

• Micrins Surgical, Inc.1 clearance
• Edward Weck, Inc.1 clearance
• Dhason Brothers, Inc.1 clearance
• Buckman Co., Inc.1 clearance
• Ace Orthopedic Manufacturing Co.1 clearance

• K890167 — HOLDER, NEEDLEDhason Brothers, Inc.·1989-02-03
• K872989 — MICRINS NEEDLE HOLDERMicrins Surgical, Inc.·1987-08-21
• K860018 — FISCHER WIRE/PIN CLAMPBuckman Co., Inc.·1986-02-07
• K801594 — ACE FISCHER EXTERNAL FIXATION DEVICEAce Orthopedic Manufacturing Co.·1980-09-09
• K772388 — CONVERSE-GILLIES NEEDLE HOLDEREdward Weck, Inc.·1978-01-20