FDA Device Establishments · JSON-LD · Markdown

ISOTIS ORTHOBIOLOGICS, INC

FEI 3001503333 · Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device · Status: Active

FEI Number3001503333
Owner / OperatorSeaSpine Orthopedics Corporation (#10049589)
Address2 Goodyear, IRVINE, CA, US
Registration expiry2026
Initial importer flagN
Registered products2
Product codes (top 20)MQV, MBP
Regulation § (21 CFR)888.3045
Proprietary namesTrel-XC Paste; OsteoSparx C Putty; OrthoBlast II Putty; OsteoSparx C Paste; Trel-XC Putty; OrthoBlast II Paste; AlloSync CB DBM; AlloSync CB DBM Putty; AlloSync CB DBM Paste

External sources

Source: openFDA. Public-domain (CC0).