Product code HTX— Orthopedic

FDA has cleared 5 devices under product code HTX between 1976 and 1987, 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.

• 19871 clearance
• 19842 clearances
• 19781 clearance
• 19761 clearance

• Plastafil, Inc.2 clearances
• Solway, Inc.1 clearance
• Orthopedic Equipment Co., Inc.1 clearance
• Depuy, Inc.1 clearance

Other

1

Total

1

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 →

• K874954 — MANUAL RONGEURSolway, Inc.·1987-12-30
• K841620 — FRONT RADIUS CUTTERPlastafil, Inc.·1984-09-20
• K841621 — BACK RADIUS CUTTERPlastafil, Inc.·1984-09-20
• K780397 — ORTHOPEDIC FORCEPSOrthopedic Equipment Co., Inc.·1978-03-22
• K760325 — SURGICAL INSTRUMENTS, ORTHOPEDICDepuy, Inc.·1976-08-03