FDA Device Entity Profile: SurgTech, Inc.

Known Identifiers & Locations

FEI Numbers 3011170410

Owner Operator Numbers 10047514

Locations Covered Westlake, OH, US

Registered Establishments (1)

Registration #	Establishment Name	Location	Establishment Type(s)	Action
3011170410	SURGTECH, INC.	Westlake, OH, US	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
K163363	SurgTech Thoracolumbosacral (TLS) Posterior Fixation System	2017-04-05	Substantially Equivalent	View Details

FDA Recall History (0)

No recall records found for this entity.

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