FDA-Device2018-02-21Class II
The ELAN 4 Air System is intended for high speed cutting, sawing and drilling of bone in fields of Spine, ENT, Neuro, and Maxillofacial Surgery.
Aesculap Implant Systems LLC
Hazard
The ELAN 4 Air System was released to the market place prior to an authorized FDA 510K clearance. This issue does not affected sales outside the United States (OUS).
Sold states
Nationwide Distribution.
Affected count
167 Units
Manufactured in
3773 Corporate Pkwy, Center Valley, PA, United States
Products
The ELAN 4 Air System is intended for high speed cutting, sawing and drilling of bone in fields of Spine, ENT, Neuro, and Maxillofacial Surgery.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0623-2018Don't want to check this manually?
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