FDA-Device2020-03-25Class II

TRUMATCH Orthognathics - Genioplasty Surgical Kit, Add-on, Catalog Number: SD980.013

Materialise N.V.
Hazard

Custom surgical kits contain a plate different than indicated by the package labeling.

Sold states
US: NY. OUS: Italy
Affected count
1
Manufactured in
Technologielaan 15, Heverlee, Belgium
Products
TRUMATCH Orthognathics - Genioplasty Surgical Kit, Add-on, Catalog Number: SD980.013

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1485-2020

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