PMA P950002S009

Device: BAK/PROXIMITY(TM) INTERBODY FUSION SYSTEM
Applicant: Zimmer Spine, Inc.
PMA number: P950002
Supplement: S009
Product code: MAX
Decision date: 2001-04-03
Generic name: Intervertebral fusion device with bone graft, lumbar
Approval order statement: APPROVAL FOR A CHANGE TO THE LABELING OF THE BAK INTERBODY FUSION SYSTEM ADDING A PRECAUTION STATEMENT (IE., THE BAK/PROXIMITY DEVICE IS TO BE USED ONLY IN CONJUNCTINO WITH A STANDARD BAK DEVICE. THE SAFETY AND EFFECTIVENESS OF THE BAK/PROXIMITY DEVICE HAS NOT BEEN ESTABLISHED WHEN USED OTHERWISE.) EFFECTIVE APRIL 1, 2001.

Current openFDA PMA Record#

Device: BAK/PROXIMITY(TM) INTERBODY FUSION SYSTEM
Applicant: Zimmer Spine, Inc.
PMA number: P950002
Supplement: S009
Product code: MAX
Generic name: Intervertebral fusion device with bone graft, lumbar
Decision date: 2001-04-03
Decision code: APPR
Date received: 2001-03-08
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR A CHANGE TO THE LABELING OF THE BAK INTERBODY FUSION SYSTEM ADDING A PRECAUTION STATEMENT (IE., THE BAK/PROXIMITY DEVICE IS TO BE USED ONLY IN CONJUNCTINO WITH A STANDARD BAK DEVICE. THE SAFETY AND EFFECTIVENESS OF THE BAK/PROXIMITY DEVICE HAS NOT BEEN ESTABLISHED WHEN USED OTHERWISE.) EFFECTIVE APRIL 1, 2001.