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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceM6-C Artificial Cervical Disc
Classification Nameprosthesis, intervertebral disc
Generic Nameprosthesis, intervertebral disc
Applicant
Spinal Kinetics LLC
501 mercury drive
sunnyvale, CA 94085
PMA NumberP170036
Date Received10/31/2017
Decision Date02/06/2019
Product Code
MJO[ Registered Establishments with MJO ]
Docket Number 19M-0645
Notice Date 02/11/2019
Advisory Committee Orthopedic
Clinical Trials NCT01609374
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the M6-C Artificial Cervical Disc. The M6-C Artificial Cervical Disc is indicated for reconstruction of the disc following single level discectomy in skeletally mature patients with intractable degenerative cervical radiculopathy with or without spinal cord compression at one level from C3 to C7. Degenerative cervical radiculopathy is defined as arm pain and/or a neurological deficit (numbness, weakness, deep tendon reflexes changes) with or without neck pain due to disc herniation and/or osteophyte formation and confirmed by radiographic imaging (CT, MRI, x-rays). The M6-C Artificial Cervical Disc is implanted via an anterior approach. Patients should have failed at least 6 weeks of conservative treatment or exhibit progressive neurological symptoms which could lead to permanent impairment prior to implantation of the M6-C Artificial Cervical Disc.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 
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