PMA P040001S016

Device: X-STOP INTERSPINOUS SPACER SYSTEM
Applicant: Medtronic Sofamor Danek, Inc.
PMA number: P040001
Supplement: S016
Product code: NQO
Decision date: 2010-04-30
Generic name: Prosthesis, spinous process spacer/plate
Approval order statement: APPROVAL FOR ADDITIONAL SURGICAL INSTRUMENTS, CHANGES TO EXISTING INSTRUMENTS AND A NEW STERILIZATION TRAY. THESE NEW COMPONENTS INCLUDE THE SIZING DISTRACTOR, THE SPACER INSERTION INSTRUMENT WITH TRI-LOBE CONNECTORS, THE BI-DIRECTIONAL SIZING DISTRACTOR, THE HORIZONTAL HANDLE, THE TRIAL SPACERS, AND THE TWO-LEVEL STERILIZATION TRAY.

Current openFDA PMA Record#

Device: X-STOP INTERSPINOUS SPACER SYSTEM
Applicant: Medtronic Sofamor Danek, Inc.
PMA number: P040001
Supplement: S016
Product code: NQO
Generic name: Prosthesis, spinous process spacer/plate
Decision date: 2010-04-30
Decision code: APPR
Date received: 2009-11-05
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR ADDITIONAL SURGICAL INSTRUMENTS, CHANGES TO EXISTING INSTRUMENTS AND A NEW STERILIZATION TRAY. THESE NEW COMPONENTS INCLUDE THE SIZING DISTRACTOR, THE SPACER INSERTION INSTRUMENT WITH TRI-LOBE CONNECTORS, THE BI-DIRECTIONAL SIZING DISTRACTOR, THE HORIZONTAL HANDLE, THE TRIAL SPACERS, AND THE TWO-LEVEL STERILIZATION TRAY.