FDA-Device2019-04-17Class II
Integra bioBLOCK Resorbable subtaler Implant, 11mm Catalog Number: 040011 - Product Usage: The bioBLOCK Implant is indicated for internal support to primary surgical interventions in the treatment of flatfoot.
Integra Limited
Hazard
Temperature indicator may have changed color to dark gray or black prior to shipment. Change in color may indicate the product exposure to temperatures greater than 110¿F
Sold states
US Nationwide distribution in the states of OH, MI.
Affected count
232 total
Manufactured in
311 Enterprise Dr, N/A, Plainsboro, NJ, United States
Products
Integra bioBLOCK Resorbable subtaler Implant, 11mm Catalog Number: 040011 - Product Usage: The bioBLOCK Implant is indicated for internal support to primary surgical interventions in the treatment of flatfoot.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1090-2019Don't want to check this manually?
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