CONDYLE IMPLANT 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	MPL
FDA Classification Name	MANDIBULAR CONDYLE PROSTHESIS
FDA Device Classification Code	Premarket Approval
FDA Regulation Number	872.3960
FDA Common Generic Name	CONDYLE IMPLANT
FDA Proprietary Device Name	CONDYLE IMPLANT
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	06-11-99
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	STRYKER LEIBINGER GMBH & CO. KG BOTZINGER STRASSE 41 FREIBURG, D-79111 GM 269-385-2600 / 49-761-4512x185	MULTIPLE	MANDIBULAR CONDYLE PROSTHESIS
2	SYNTHES (USA) 1051-1101 SYNTHES AVE. MONUMENT, CO 80132 US 610-719-5000 / 484-356-9728	MANIDBULAR CONDYLE PROSTHESIS	LOCKING RECONSTRUCTION PLATE WITH CONDYLAR HEAD
3	SYNTHES BETTLACH GMBH MURACHERSTRASSE 3 BETTLACH, SO, 2544 SZ 41-32-6441644 / 41-61-965 62 22	LOCKING RECONSTRUCTION PLATE WITH CONDYLAR HEAD	VARIOUS SIZES OF LOCKING RECONSTRUCTION PLATES CONDYLAR HEAD
4	SYNTHES GMBH EIMATTSTRASSE 3 OBERDORF, CH-4436 SZ 41-32-6441644 / 41-61-965 62 22	LOCKING RECONSTRUCTION PLATE WITH CONDYLAR HEAD	VARIOUS SIZES OF LOCKING RECONSTRUCTION PLATES WITH CONDYLAR HEAD