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.
| Device | M6-C Artificial Cervical Disc |
| Classification Name | Prosthesis, Intervertebral Disc |
| Generic Name | Prosthesis, Intervertebral Disc |
| Applicant | Spinal Kinetics LLC |
| Date Received | 2017-10-31 |
| Decision Date | 2019-02-06 |
| Notice Date | 2019-02-11 |
| PMA | P170036 |
| Supplement | S |
| Product Code | MJO |
| Docket Number | 19M-0645 |
| Advisory Committee | Orthopedic |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Spinal Kinetics LLC 501 Mercury Drive sunnyvale, CA 94085 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P170036 | Original Filing | |
| S012 | 2022-10-17 | 30-day Notice |
| S011 | 2022-06-09 | 30-day Notice |
| S010 | 2022-03-08 | 30-day Notice |
| S009 | 2021-09-29 | 30-day Notice |
| S008 | 2020-12-22 | Normal 180 Day Track No User Fee |
| S007 | 2020-09-17 | 30-day Notice |
| S006 | 2020-09-11 | Normal 180 Day Track No User Fee |
| S005 | 2020-02-05 | 30-day Notice |
| S004 | 2020-01-09 | 30-day Notice |
| S003 | 2019-08-15 | 30-day Notice |
| S002 | 2019-04-17 | 30-day Notice |
| S001 |