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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.
Classification Nameprosthesis, intervertebral disc
PMA NumberP120024
Date Received12/18/2012
Decision Date06/11/2015
Product Code
MJO[ Registered Establishments with MJO ]
Docket Number 15M-2218
Notice Date 07/17/2015
Advisory Committee Orthopedic
Clinical Trials NCT00589797
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the activl® artificial disc. This device is indicated for reconstruction of the disc at one level (l4-l5 or l5-s1) following single-level discectomy in skeletally mature patients with symptomatic degenerative disc disease (ddd) with no more than grade i spondylolisthesis at the involved level. Ddd is defined as discogenic back pain with degeneration of the disc confirmed by patient history, physical examination, and radiographic studies. The activl® artificial disc is implanted using an anterior retroperitoneal approach. Patients receiving the activl® artificial disc should have failed at least six months of nonoperative treatment prior to implantation of the device.
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003