Product code HXJ— Orthopedic

FDA has cleared 6 devices under product code HXJ between 1983 and 1997, 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.

• 19971 clearance
• 19961 clearance
• 19931 clearance
• 19841 clearance
• 19832 clearances

• Influence, Inc.2 clearances
• Techmedica, Inc.1 clearance
• Stryker Corp.1 clearance
• Micro Surgical Instruments Corp.1 clearance
• Instrument Makar, Inc.1 clearance

• K964953 — IN-TAC BONE ANCHOR SYSTEMInfluence, Inc.·1997-02-13
• K962372 — UROTAC BONE ANCHOR INSERTERInfluence, Inc.·1996-08-19
• K930205 — ELECTRIC WIRE DRIVER, MODEL 2640EMicro Surgical Instruments Corp.·1993-08-02
• K834515 — FIXATION STAPLE KIT - DLIDE HAMMERStryker Corp.·1984-04-23
• K830255 — OSTEOTOMY BONE STAPLETechmedica, Inc.·1983-03-09
• K830456 — STAPLE INSERTER-EXTRACTOR FOR ARTHROSInstrument Makar, Inc.·1983-03-09