FDA Device Entity Profile: Bioplate, Inc.

Known Identifiers & Locations

FEI Numbers 1000518793

Owner Operator Numbers 9016123

Locations Covered Placentia, CA, US

Registered Establishments (1)

Registration #	Establishment Name	Location	Establishment Type(s)	Action
2029447	BIOPLATE, INC.	Placentia, CA, US	Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198,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-0043-2007	Bioplate Resorbable Bone Fixation Tack, Catalog Number: 89-0120, Item Number: SG#-45 Reason: Lack of device sterilization: An internal investigation found products were released for distribution labeled as sterile, but the lot was not sterilized.	2006-09-12	Terminated	View Details

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