Product code HXL— General, Plastic Surgery

FDA has cleared 3 devices under product code HXL between 1987 and 1988, filed by 3 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.

• 19881 clearance
• 19872 clearances

• Treace Medical, Inc.1 clearance
• New England Surgical Instrument Corp.1 clearance
• Military Engineering, Inc.1 clearance

• K882349 — MALLET, SURGICALTreace Medical, Inc.·1988-06-23
• K872209 — ARTHROPLASTY MALLETNew England Surgical Instrument Corp.·1987-06-23
• K871195 — MALLET, BONE SURGERY, STAINLESS STEEL, 2LB.Military Engineering, Inc.·1987-04-06