Recipient Title Vice President and General Manager of Spine Operations, IsoTis OrthoBiologics, Inc., 2 Goodyear, Ste A, Irvine , CA 92618 United States, (b)(4)
Issue DateFebruary 24, 2026
FEI NumberN/A
Violations3
CountryUnited States
Issuing Office
Center for Devices and Radiological Health
Product Type
Medical Devices
Status
Open
Subject
CGMP/QSR/Medical Devices/Adulterated
IsoTis OrthoBiologics, Inc. FDA Warning Letter, February 24, 2026
