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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameBAK/CERVICAL (BAK/C) INTERBODY FUSION SYSTEM
Classification Nameintervertebral fusion device with bone graft, lumbar
Generic Namecervical interbody fusion instrumentation
Regulation Number888.3080
ApplicantSULZER SPINE-TECH
PMA NumberP980048
Date Received12/15/1998
Decision Date04/20/2001
Reclassified Date 07/12/2007
Product Code
MAX[ Registered Establishments with MAX ]
Docket Number 03M-0122
Notice Date 03/31/2003
Advisory Committee Orthopedic
Expedited Review Granted? Yes
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the bak/cervical (bak/c(r)) interbody fusion system. The device is indicated for use in skeletally mature patients with degenerative disc disease (ddd) of the cervical spine with accompanying radicular symptoms at one disc level. Ddd is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. Bak/c implants are used to facilitate fusion in the cervical spine and are placed via an anterior approach at the c-3 to c-7 disc levels using autograft bone.
Approval Order Approval Order
Supplements: S001 S002 S003 
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