FDA Device Entity Profile: SIGNUS Medizintechnik GmbH

Known Identifiers & Locations

FEI Numbers 1000615957

Owner Operator Numbers 9034279

Locations Covered ALZENAU Bavaria, DE

Registered Establishments (1)

Registration #	Establishment Name	Location	Establishment Type(s)	Action
9615021	SIGNUS MEDIZINTECHNIK GMBH	ALZENAU Bavaria, DE	Complaint File Establishment per 21 CFR 820.198,Export Device to the United States But Perform No Other Operation on Device,Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device	View Details

510(k) Premarket Notifications (1)

Submission #	Device Name	Decision Date	Decision Description	Action
K041888	CURVED PEEK TETRIS SPINAL IMPLANT	2004-08-10	Substantially Equivalent	View Details

FDA Recall History (0)

No recall records found for this entity.

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