PMA P110008S008

Device: coflex® Interlaminar Technology
Applicant: Companion Spine France
PMA number: P110008
Supplement: S008
Product code: NQO
Decision date: 2018-04-25
Classification: Prosthesis, Spinous Process Spacer/plate
Generic name: Prosthesis, spinous process spacer/plate
Approval order statement: Approval for introducing a set of disposable instruments for the coflex® and for Otto Klumpp to manufacture these disposable instruments at Burgstraße 18, 72336, Balingen-Ostdorf, Germany.

Current openFDA PMA Record#

Device: coflex® Interlaminar Technology
Applicant: Companion Spine France
PMA number: P110008
Supplement: S008
Product code: NQO
Generic name: Prosthesis, spinous process spacer/plate
Decision date: 2018-04-25
Decision code: APPR
Date received: 2017-06-26
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for introducing a set of disposable instruments for the coflex® and for Otto Klumpp to manufacture these disposable instruments at Burgstraße 18, 72336, Balingen-Ostdorf, Germany.