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Devices
ELAN 4 Air System
Model / Serial
ELAN 4 Air System ST0607 ELAN 4 Air Control Set ST0608 ELAN 4 Air Neuro Crani Set ST0609 ELAN 4 Air Spine Set ST06411 ELAN 4 Air HD Spine Set ST0614 ELAN 4 Air Micro Saw Set ST0615 ELAN 4 Air Hand Control Set ST0638 ELAN 4 Air Large Saw Set
Product Classification
Neurological Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution.
Product Description
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.
Manufacturer
Aesculap Implant Systems LLC
1 Event
Recall of ELAN 4 Air System
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Manufacturer
Aesculap Implant Systems LLC
Manufacturer Address
Aesculap Implant Systems LLC, 3773 Corporate Pkwy, Center Valley PA 18034-8217
Manufacturer Parent Company (2017)
Ludwig G. Braun Gmbh U. Co. Kg
Source
USFDA
Language
English
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