PMA P980048S002

Device: BAK/CERVICAL (BAK/C) (R) INTERBODY FUSION SYSTEM
Applicant: Sulzer Spine-Tech
PMA number: P980048
Supplement: S002
Product code: MAX
Decision date: 2002-06-19
Classification: Orthopedic
Generic name: Intervertebral fusion device with bone graft, lumbar
Approval order statement: APPROVAL FOR THE POST-APPROVAL STUDY PROTOCOL FOR THE BAC/C DEVICE. THE POST-APPROVAL STUDY HAS BEEN SUBMITTED TO COMPLY WITH THE CONDITIONS OF APPROVAL OUTLINED IN THE APRIL 20, 2001, APPROVAL ORDER FOR P980048.

Current openFDA PMA Record#

Device: BAK/CERVICAL (BAK/C) (R) INTERBODY FUSION SYSTEM
Applicant: Sulzer Spine-Tech
PMA number: P980048
Supplement: S002
Product code: MAX
Generic name: Intervertebral fusion device with bone graft, lumbar
Decision date: 2002-06-19
Decision code: APPR
Date received: 2001-06-22
Supplement type: Normal 180 Day Track
Supplement reason: Postapproval Study Protocol
Approval order statement: APPROVAL FOR THE POST-APPROVAL STUDY PROTOCOL FOR THE BAC/C DEVICE. THE POST-APPROVAL STUDY HAS BEEN SUBMITTED TO COMPLY WITH THE CONDITIONS OF APPROVAL OUTLINED IN THE APRIL 20, 2001, APPROVAL ORDER FOR P980048.