Product code KWM— Orthopedic

FDA has cleared 6 devices under product code KWM between 1979 and 1988, filed by 5 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.

• 19881 clearance
• 19871 clearance
• 19821 clearance
• 19802 clearances
• 19791 clearance

• Depuy, Inc.2 clearances
• Protek, Inc.1 clearance
• Laure Prosthetics, Inc.1 clearance
• Dow Corning Wright1 clearance
• Biomet, Inc.1 clearance

• K880156 — VOLZ TOTAL WRIST PROSTHESISBiomet, Inc.·1988-02-17
• K872502 — M.W.P. WRIST PROSTHESISProtek, Inc.·1987-07-23
• K803031 — LAURE WRIST IMPLANTLaure Prosthetics, Inc.·1982-06-29
• K800602 — TALEISNIK TOTAL WRIST PROSTHESISDow Corning Wright·1980-08-27
• K801157 — WEBER-MAYO WRISTDepuy, Inc.·1980-08-04
• K790774 — LODA WRIST PROSTHESISDepuy, Inc.·1979-08-03