FDA-Device2018-05-23Class II
Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1001 (Small)
Kelyniam Global, Inc.
Hazard
Significant design changes made to the Custom Skull Implant (CSI) devices, such as removing pressure relief holes across the length of the device and adding suture holes along the ridge of the implant, were not validated or submitted to FDA for marketing clearance. The Temporal Suture System (TSS) is no longer being offered and the Integrated Fixation System (IFS) has been temporarily suspended
Sold states
US nationwide distribution.
Affected count
2
Manufactured in
97 River Rd, Collinsville, CT, United States
Products
Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1001 (Small)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1870-2018Don't want to check this manually?
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