PMA P950002S004

Device: BAK INTERBODY FUSION SYSTEM
Applicant: Zimmer Spine, Inc.
PMA number: P950002
Supplement: S004
Product code: MAX
Decision date: 1997-06-30
Generic name: Intervertebral fusion device with bone graft, lumbar
Approval order statement: APPROVAL OF DESIGN CHANGES TO THE INSERTION END OF THE POLYETHYLENE ENDCAP AND THE INSERTION TOOLS USED AS PART OF THE BAK INTERBODY FUSION SYSTEM.

Current openFDA PMA Record#

Device: BAK INTERBODY FUSION SYSTEM
Applicant: Zimmer Spine, Inc.
PMA number: P950002
Supplement: S004
Product code: MAX
Generic name: Intervertebral fusion device with bone graft, lumbar
Decision date: 1997-06-30
Decision code: APPR
Date received: 1997-06-13
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL OF DESIGN CHANGES TO THE INSERTION END OF THE POLYETHYLENE ENDCAP AND THE INSERTION TOOLS USED AS PART OF THE BAK INTERBODY FUSION SYSTEM.