FDA-Device2014-01-01Class II
ProPlan CMF Guide(s) Model(s) REF SD900.008 Description: Single Use Only : Patient-Specific Guide, Orthognathic, Intermediate Single Use Only Rx only. Used as surgical tools to transfer a pre-operative plan to surgery.
Materialise USA LLC
Hazard
Patient Specific Guide contained the incorrect case report. The case report contains patient specific surgical plan information.
Sold states
Distributed in Canada.
Affected count
1
Manufactured in
44650 Helm Ct, N/A, Plymouth, MI, United States
Products
ProPlan CMF Guide(s) Model(s) REF SD900.008 Description: Single Use Only : Patient-Specific Guide, Orthognathic, Intermediate Single Use Only Rx only. Used as surgical tools to transfer a pre-operative plan to surgery.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0577-2014Don't want to check this manually?
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