FDA Device Entity Profile: INTEGRATED ORBITAL IMPLANTS INC

Known Identifiers & Locations

FEI Numbers 3009688114

Owner Operator Numbers 2027377

Locations Covered SAN DIEGO, CA, US

Registered Establishments (1)

Registration #	Establishment Name	Location	Establishment Type(s)	Action
2027377	INTEGRATED ORBITAL IMPLANTS, INC.	SAN DIEGO, CA, US	Repack or Relabel Medical Device,Develop Specifications But Do Not Manufacture At This Facility	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-0012-2007	Bio-Eye Hydroxyapatite (HA) Orbital Implant and Conformer, Model Number: 100020S Reason: The end label on the outer box was mislabeled on 9 of a 10 unit lot. The end label says ''22 mm'' and the implants are actually ''20 mm''. The main label on the cardboard box applied by the contract packager is correct in identifying the product as ''20 mm''.	2006-02-27	Terminated	View Details

Profile Disclaimer

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