FDA Device Entity Profile: Ortho Development Corporation

Known Identifiers & Locations

FEI Numbers 1000143502, 3017298928

Owner Operator Numbers 9012515

Locations Covered DRAPER, UT, US

Registered Establishments (1)

Registration #	Establishment Name	Location	Establishment Type(s)	Action
1722511	ORTHO DEVELOPMENT CORP.	DRAPER, UT, US	Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device	View Details

510(k) Premarket Notifications (0)

No 510(k) notifications found for this entity.

FDA Recall History (1)

Recall #	Product Description	Initiation Date	Status	Action
Z-0042-04	Guide pin (component of the Tibial Punch Guide) of the Balanced Knee System. Reason: The guide pin which rotationally constrains the tibial punch within the punch guide, may fall out.	2003-09-15	Terminated	View Details

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