This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Approval of the revised protocol for the post-approval study (pas) referenced above. The pas protocol has been submitted to comply with the conditions of approval outlined in our approval order for p110008.
| Device | coflex Interlaminar Stabilization |
| Generic Name | Prosthesis, Spinous Process Spacer/plate |
| Applicant | Surgalign Spine Technologies, Inc. |
| Date Received | 2021-01-06 |
| Decision Date | 2021-03-31 |
| PMA | P110008 |
| Supplement | S013 |
| Product Code | NQO |
| Advisory Committee | Orthopedic |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Postapproval Study Protocol - Ode/oir |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Surgalign Spine Technologies, Inc. 520 Lake Cook Road suite 315 deerfield, IL 60015 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P110008 | Original Filing | |
| S013 | 2021-01-06 | Normal 180 Day Track No User Fee |
| S012 | 2020-07-09 | Special (immediate Track) |
| S011 | 2019-10-29 | Normal 180 Day Track No User Fee |
| S010 | 2017-08-17 | Normal 180 Day Track No User Fee |
| S009 | 2017-07-03 | Normal 180 Day Track No User Fee |
| S008 | 2017-06-26 | Normal 180 Day Track |
| S007 | 2016-10-18 | Normal 180 Day Track No User Fee |
| S006 | 2016-09-01 | Real-time Process |
| S005 | 2016-03-09 | Normal 180 Day Track No User Fee |
| S004 | 2016-01-14 | 30-day Notice |
| S003 | 2014-02-19 | Normal 180 Day Track No User Fee |
| S002 | 2012-11-26 | Normal 180 Day Track No User Fee |
| S001 | 2012-11-26 | Normal 180 Day Track No User Fee |