Product code JDJ— General, Plastic Surgery

FDA has cleared 7 devices under product code JDJ between 1989 and 1997, filed by 6 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 19973 clearances
• 19962 clearances
• 19931 clearance
• 19891 clearance

• Osteonics Corp.2 clearances
• Smith & Nephew Richards, Inc.1 clearance
• Link America, Inc.1 clearance
• Intermedics Orthopedics1 clearance
• Howmedica, Inc.1 clearance
• Depuy, Inc.1 clearance

• K972760 — LINK, ACETABULAR REVISION MESH CUPLink America, Inc.·1997-10-22
• K970957 — OSTEONICS RESTORATION ACETABULAR RINGOsteonics Corp.·1997-06-03
• K963940 — EXETER MESHHowmedica, Inc.·1997-02-13
• K962541 — REFLECTION ACETABULAR REINFORCEMENT RINGSSmith & Nephew Richards, Inc.·1996-09-17
• K962007 — PROTRUSION CAGESDepuy, Inc.·1996-08-01
• K925883 — OSTEONICS MICROSTRUCTURED ACETABULAR COMPONENTSOsteonics Corp.·1993-06-15
• K890450 — INTERMEDICS APR(TM) II FEMORAL COMPONENTIntermedics Orthopedics·1989-08-09