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.
Approval for the prodisc-c total disc replacement. The device is indicated for skeletally mature patients for reconstruction of the disc from c3-c7 following single-level discectomy for intractable symptomatic cervical disc disease (scdd). Symptomatic cervical disc disease is defined as neck or arm (radicular) pain and/or a functional/neurological deficit with at least one of the following conditions confirmed by imaging (ct, mri, or x-rays): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or loss of disc height. The prodisc-c total disc replacement is implanted via an open anterior approach. Patients receiving the prodisc-c total disc replacement should have failed at least six weeks of non-operative treatment prior to implantation of the prodisc-c total disc replacement.
| Device | PRODISC TM-C TOTAL DISC REPLACEMENT |
| Classification Name | Prosthesis, Intervertebral Disc |
| Generic Name | Prosthesis, Intervertebral Disc |
| Applicant | Centinel Spine, LLC |
| Date Received | 2007-01-03 |
| Decision Date | 2007-12-17 |
| Notice Date | 2008-01-10 |
| PMA | P070001 |
| Supplement | S |
| Product Code | MJO |
| Docket Number | 08M-0013 |
| Advisory Committee | Orthopedic |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Centinel Spine, LLC 900 Airport Road, Suite 3b west Chester, PA 19380 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P070001 | Original Filing | |
| S021 | 2021-09-21 | 30-day Notice |
| S020 | 2021-01-28 | 30-day Notice |
| S019 | ||
| S018 | 2019-06-21 | Normal 180 Day Track No User Fee |
| S017 | 2018-12-04 | Normal 180 Day Track No User Fee |
| S016 | 2017-09-20 | 30-day Notice |
| S015 | 2017-06-30 | 30-day Notice |
| S014 | ||
| S013 | 2014-04-03 | 135 Review Track For 30-day Notice |
| S012 | 2012-03-13 | 135 Review Track For 30-day Notice |
| S011 | 2011-07-19 | 30-day Notice |
| S010 | 2011-07-18 | 135 Review Track For 30-day Notice |
| S009 | 2010-08-02 | Real-time Process |
| S008 | 2010-06-07 | 30-day Notice |
| S007 | 2010-06-02 | 30-day Notice |
| S006 | 2010-05-27 | 30-day Notice |
| S005 | 2010-05-27 | 135 Review Track For 30-day Notice |
| S004 | 2010-05-19 | Normal 180 Day Track No User Fee |
| S003 | ||
| S002 | 2008-03-12 | Normal 180 Day Track No User Fee |
| S001 | 2008-01-31 | Real-time Process |