Product code HXY— Orthopedic

FDA has cleared 7 devices under product code HXY between 1977 and 1992, filed by 6 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.

• 19921 clearance
• 19891 clearance
• 19883 clearances
• 19831 clearance
• 19771 clearance

• Orthopedic Systems, Inc.2 clearances
• Neimark Labs, Inc.1 clearance
• Mitek Surgical Products, Inc.1 clearance
• Depuy, Inc.1 clearance
• Buckman Co., Inc.1 clearance
• Austin Assoc.1 clearance

• K923776 — BENDEREV DRILL GUIDENeimark Labs, Inc.·1992-11-06
• K892904 — MITEK DRILL GUIDEMitek Surgical Products, Inc.·1989-09-28
• K880264 — BONE SUTURE FIXATION DEVICEOrthopedic Systems, Inc.·1988-03-23
• K880381 — TELOS DISTAL TARGETING DEVICEAustin Assoc.·1988-03-15
• K880046 — HASTING FINGER FIXATOR INSTRUMENTSBuckman Co., Inc.·1988-02-16
• K831043 — ANDREWS REMOTE CHUCK DRILLOrthopedic Systems, Inc.·1983-04-28
• K770204 — CEMENT EXTRACTOR DRILLDepuy, Inc.·1977-02-08