ORTHODONTIC ANCHORAGE SYSTEM MANUFACTURED BY BIOMET MICROFIXATION, INC.

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Request for Information Form	Contact Information
Company Name	BIOMET MICROFIXATION, INC.
Address	1520 TRADEPORT DR.
City, State, Zip	JACKSONVILLE, FL 32218
Country	US
FDA Owner/Operator Phone	800-874-7711
FDA Medical Specialty Code	DE - Dental
FDA Product Code	OAT
FDA Classification Name	IMPLANT, ENDOSSEOUS, ORTHODONTIC
FDA Device Classification Code	Standards
FDA Regulation Number	872.3640
FDA Common Generic Name	BONE PLATES AND SCREWS
FDA Proprietary Device Name	ORTHODONTIC ANCHORAGE SYSTEM
FDA Owner / Operator Number	1032347
FDA Owner / Operator Name	BIOMET MICROFIXATION, INC.
FDA Establishment Registration Number	1032347
FDA Registered Establishment Name	BIOMET MICROFIXATION, INC.
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	02-13-07
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Our records indicate that the following medical device companies may manufacture a similar device.

	Company Name / Address / Phone	Proprietary Device Name	Common Generic Device Name
1	ALPHA BIO TEC LTD. 7 EMBAR ST. I.Z. KIRYAT ARIE, POB 3936 PETACH-TIKVA, 49130 IS / 202-885-5548	ALPHA BIO TEC ORTODONTIC FIXATION SCREW SYSTEM	ORTHODONTIC FIXATION SCREW
2	BIOMATERIALS KOREA INC. ROOM 512, KOLON SCIENCE VALLEY 811, GURO-DONG, GURO-GU SEOUL, 152-050 KS 82-220-250720 / 82-220-250720	MULTIPLE	VARIOUS MODELS OF ORTHODONTIC ANCHOR SCREWS
3	ORMCO CORP. 1332 SOUTH LONE HILL AVE. GLENDORA, CA 91740 US 714-516-7400 / 714-516-7484	VECTORS TEMPORARY ANCHORAGE SYSTEM	ORTHODONTIC IMPLANT SCREW
4	SYNTHES (USA) 35 AIRPORT RD. HORSEHEADS, NY 14845 US 610-719-5000 / 484-356-9728	ORTHODONTIC BONE ANCHOR SYSTEM	BONE PLATE AND SCREWS
5	SYNTHES (USA) 1051-1101 SYNTHES AVE. MONUMENT, CO 80132 US 610-719-5000 / 484-356-9728	ORTHODONTIC BONE ANCHOR SYSTEM	BONE PLATE AND SCREWS