PMA P110008S005

Device: COFLEX® INTERLAMINAR TECHNOLOGY
Applicant: Companion Spine France
PMA number: P110008
Supplement: S005
Product code: NQO
Decision date: 2016-08-23
Generic name: Prosthesis, spinous process spacer/plate
Approval order statement: Approval for the manufacturing sites located at 6688 Dixie Highway, Bridgeport, MI 48722 for the packaging and labeling of the coflex Interlaminar Technology; 11911 Clark Street, Arcadia, CA 91006 for the laser marking, in-process cleaning, and inspection of the coflex Interlaminar Technology; and 1880 Industrial Drive, Libertyville, IL 60048 for the sterilization of the coflex Interlaminar Technology.

Current openFDA PMA Record#

Device: COFLEX® INTERLAMINAR TECHNOLOGY
Applicant: Companion Spine France
PMA number: P110008
Supplement: S005
Product code: NQO
Generic name: Prosthesis, spinous process spacer/plate
Decision date: 2016-08-23
Decision code: APPR
Date received: 2016-03-09
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for the manufacturing sites located at 6688 Dixie Highway, Bridgeport, MI 48722 for the packaging and labeling of the coflex Interlaminar Technology; 11911 Clark Street, Arcadia, CA 91006 for the laser marking, in-process cleaning, and inspection of the coflex Interlaminar Technology; and 1880 Industrial Drive, Libertyville, IL 60048 for the sterilization of the coflex Interlaminar Technology.