FDA Device Entity Profile: Stryker Instruments, Instruments Div.

Known Identifiers & Locations

FEI Numbers 1811755

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
K072702	STRYKER ANTIMIC CATHETER	2008-03-19	Substantially Equivalent	View Details

FDA Recall History (2)

Recall #	Product Description	Initiation Date	Status	Action
Z-0020-05	Stryker Navigation System - Hip Module Patient Tracker, green; Model 6007-005-000. Reason: The tracker is not locking adequately to the anchoring pin, resulting in unacceptable movement, which will affected the patient tracker system.	2004-07-14	Terminated	View Details
Z-0021-05	Stryker Navigation System - Hip Module Patient Tracker, blue; Model 6007-010-000. Reason: The tracker is not locking adequately to the anchoring pin, resulting in unacceptable movement, which will affected the patient tracker system.	2004-07-14	Terminated	View Details

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