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Device | M6-C Artificial Cervical Disc |
Generic Name | Prosthesis, intervertebral disc |
Applicant | Spinal Kinetics LLC 501 Mercury Drive Sunnyvale, CA 94085 |
PMA Number | P170036 |
Date Received | 10/31/2017 |
Decision Date | 02/06/2019 |
Product Code |
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 Study | Show Report Schedule and Study Progress |
Supplements: |
S003 S002 S006 S007 S009 S008 S001 S004 S005 S013 S012 S011 S010 |