FDA-Device2015-10-28Class II
ConFormis iTotal CR Knee Replacement System- ITOTAL CR - IPOLY - IMPLANT KIT UNCAPTURED - LEFT ITOTAL CR - IPOLY - IMPLANT KIT UNCAPTURED - RIGHT Catalog Number: TCR1111111
ConforMIS, Inc.
Hazard
May contain small amounts of ethylene glycol residue
Sold states
Distributed Nationwide and in Germany, Switzerland, and UK.
Affected count
3 units
Manufactured in
28 Crosby Dr, N/A, Bedford, MA, United States
Products
ConFormis iTotal CR Knee Replacement System- ITOTAL CR - IPOLY - IMPLANT KIT UNCAPTURED - LEFT ITOTAL CR - IPOLY - IMPLANT KIT UNCAPTURED - RIGHT Catalog Number: TCR1111111
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0144-2016Don't want to check this manually?
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