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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 NameINTER FIX THREADED FUSION DEVICE
Classification Nameintervertebral fusion device with bone graft, lumbar
Generic Nameintervertebral body fusion device
Regulation Number888.3080
ApplicantSOFAMOR DANEK
PMA NumberP970015
Date Received03/25/1997
Decision Date05/14/1999
Reclassified Date 07/12/2007
Product Code
MAX[ Registered Establishments with MAX ]
Docket Number 99M-4277
Advisory Committee Orthopedic
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Recalls CDRH Recalls
Approval Order Statement 
Approvalf or the inter fix(tm) threaded fusion device. This device is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (ddd) at one level from l2-s1. Ddd is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These ddd patients may also have up to grade i spondylolisthesis or retrolisthesis at the involved level. Inter fix(tm) implants are indicated to be used with autogenous bone graft and implanted via an open anterior approach.
Approval Order Approval Order
Supplements: S001 S002 S003 S005 S008 S009 S010 S011 S013 
S014 S017 S019 S020 S021 S022 S025 S026 S027 
S028 S029 S030 S031 
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