FDA-Device2014-01-01Class II
ProPlan CMF Guide(s) Model(s) REF SD900.008 Description: Single Use Only : Patient-Specific Guide, Orthognathic, Final 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, Final 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-0578-2014Don't want to check this manually?
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