PMA P950002S002

Device: BAK INTERBODY FUSION SYSTEM
Applicant: Zimmer Spine, Inc.
PMA number: P950002
Supplement: S002
Product code: MAX
Decision date: 1997-05-09
Generic name: Intervertebral fusion device with bone graft, lumbar
Approval order statement: APPROVAL OF THE ADDITION OF THE FOLLOWING SIZES TO THE BAK PRODUCT LINE: A) BAK IMPLANTS (MINOR DIAMETER (MM) X LENGTH (MM)) 11X20, 11X24, 11X28, 11X32, 11X36; 13X24, 13X28, 13X32, 13X36, 13X40; 15X28, 15X32, 15X36, 15X40, 15X44; 17X20, 17X32, 17X36, 17X40, 17X44; 19X24, 19X28, 19X32, 19X36, 19X40, 19X44; 21X28, 21X32, 21X36, 21X40, 21X44; AND (B) END CAPS (DIAMETER (MM)) 11; 19; AND 21.

Current openFDA PMA Record#

Device: BAK INTERBODY FUSION SYSTEM
Applicant: Zimmer Spine, Inc.
PMA number: P950002
Supplement: S002
Product code: MAX
Generic name: Intervertebral fusion device with bone graft, lumbar
Decision date: 1997-05-09
Decision code: APPR
Date received: 1997-02-05
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL OF THE ADDITION OF THE FOLLOWING SIZES TO THE BAK PRODUCT LINE: A) BAK IMPLANTS (MINOR DIAMETER (MM) X LENGTH (MM)) 11X20, 11X24, 11X28, 11X32, 11X36; 13X24, 13X28, 13X32, 13X36, 13X40; 15X28, 15X32, 15X36, 15X40, 15X44; 17X20, 17X32, 17X36, 17X40, 17X44; 19X24, 19X28, 19X32, 19X36, 19X40, 19X44; 21X28, 21X32, 21X36, 21X40, 21X44; AND (B) END CAPS (DIAMETER (MM)) 11; 19; AND 21.