PMA P020016S002

Device: TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM
Applicant: Biomet Microfixation, Inc.
PMA number: P020016
Supplement: S002
Product code: LZD
Decision date: 2006-10-13
Generic name: Joint, temporomandibular, implant
Approval order statement: APPROVAL FOR A MANUFACTURING SITE LOCATED AT ARTHROTEK, INC.?S ONTARIO CALIFORNIA, FACILITY FOR THE PURCHASE OF RAW MATERIAL FOR THE MANDIBULAR BLANKS; THE CUTTING OF THIS RAW MATERIAL; AND THE ADDITION OF ANOTHER WIRE ELECTRICAL DISCHARGE MACHINE.

Current openFDA PMA Record#

Device: TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM
Applicant: Biomet Microfixation, Inc.
PMA number: P020016
Supplement: S002
Product code: LZD
Generic name: Joint, temporomandibular, implant
Decision date: 2006-10-13
Decision code: APPR
Date received: 2006-09-11
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A MANUFACTURING SITE LOCATED AT ARTHROTEK, INC.?S ONTARIO CALIFORNIA, FACILITY FOR THE PURCHASE OF RAW MATERIAL FOR THE MANDIBULAR BLANKS; THE CUTTING OF THIS RAW MATERIAL; AND THE ADDITION OF ANOTHER WIRE ELECTRICAL DISCHARGE MACHINE.