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-l total disc replacement. The device is indicated for spinal arthroplasty in skeletally mature patients with degenerative disc disease (ddd) at one level from l3-s1. Ddd is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These ddd patients should have no more than grade 1 spondylolisthesis at the involved level. Patients receiving the prodisc-l total disc replacement should have failed at least six months of conservative treatment prior to implantation of the prodisc-l total disc replacement.
| Device | PRODISC -L TOTAL DISC REPLACEMENT DEVICE |
| Classification Name | Prosthesis, Intervertebral Disc |
| Generic Name | Prosthesis, Intervertebral Disc |
| Applicant | Centinel Spine, LLC |
| Date Received | 2005-03-15 |
| Decision Date | 2006-08-14 |
| Notice Date | 2006-08-25 |
| PMA | P050010 |
| Supplement | S |
| Product Code | MJO |
| Docket Number | 06M-0343 |
| 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 Labeling Part 2 |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P050010 | Original Filing | |
| S023 | 2021-03-01 | 30-day Notice |
| S022 | 2019-09-09 | Real-time Process |
| S021 | ||
| S020 | ||
| S019 | 2017-10-18 | 30-day Notice |
| S018 | ||
| S017 | 2016-01-15 | 30-day Notice |
| S016 | 2014-04-03 | 135 Review Track For 30-day Notice |
| S015 | ||
| S014 | 2012-12-07 | Normal 180 Day Track |
| S013 | 2012-11-08 | Normal 180 Day Track No User Fee |
| S012 | 2011-04-26 | Real-time Process |
| S011 | 2011-01-28 | 135 Review Track For 30-day Notice |
| S010 | 2010-09-29 | 135 Review Track For 30-day Notice |
| S009 | 2010-09-15 | 135 Review Track For 30-day Notice |
| S008 | 2010-08-02 | Real-time Process |
| S007 | 2010-05-19 | Normal 180 Day Track No User Fee |
| S006 | 2010-04-26 | 30-day Notice |
| S005 | 2010-04-26 | 30-day Notice |
| S004 | ||
| S003 | 2008-07-28 | 30-day Notice |
| S002 | 2008-05-29 | 135 Review Track For 30-day Notice |
| S001 | 2007-12-26 | Real-time Process |
| Device ID | PMA | Supp |
|---|---|---|
| 10705034700182 | P050010 | 000 |
| H981PDLMIP00S0D | P050010 | 000 |
| H981PDLLSP11S0O | P050010 | 000 |
| H981PDLLSP06S0S | P050010 | 000 |
| H981PDLLPT14S0S | P050010 | 000 |
| H981PDLLPT12S0Q | P050010 | 000 |
| H981PDLLPT10S0O | P050010 | 000 |
| H981PDLLIP00S0C | P050010 | 000 |
| 00843193114983 | P050010 | 000 |
| 00843193114976 | P050010 | 000 |
| 00843193114969 | P050010 | 000 |
| 00843193114952 | P050010 | 000 |
| 00843193114945 | P050010 | 000 |
| 00843193114938 | P050010 | 000 |
| H981PDLMPT10S0P | P050010 | 000 |
| H981PDLMPT12S0R | P050010 | 000 |
| 10705034700175 | P050010 | 000 |
| 10705034700151 | P050010 | 000 |
| 10705034700144 | P050010 | 000 |
| 10705034700137 | P050010 | 000 |
| 10705034700106 | P050010 | 000 |
| 10705034700090 | P050010 | 000 |
| 10705034700083 | P050010 | 000 |
| 10705034700069 | P050010 | 000 |
| 10705034700052 | P050010 | 000 |
| 10705034700045 | P050010 | 000 |
| H981PDLMSP11S0P | P050010 | 000 |
| H981PDLMSP06S0T | P050010 | 000 |
| H981PDLMPT14S0T | P050010 | 000 |
| 00843193111692 | P050010 | 000 |