FDA Device Entity Profile: Linvatec Corp.

Known Identifiers & Locations

FEI Numbers 1017294

Owner Operator Numbers N/A

Locations Covered N/A

Registered Establishments (0)

No device registration and listing records found for this entity.

510(k) Premarket Notifications (1)

Submission #	Device Name	Decision Date	Decision Description	Action
K964548	APEX UNIVERSAL DRIVE SYSTEM	1997-01-17	Substantially Equivalent	View Details

FDA Recall History (1)

Recall #	Product Description	Initiation Date	Status	Action
Z-0041-05	Ultra Power Burs, Sterile, Single-Use. Reason: The pouch containing the sterile product is not completely seal on all products. Therefore , the sterility of the device is questionable.	2004-08-26	Terminated	View Details

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