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 for the manufacturing sites located at 6688 dixie highway, bridgeport, mi 48722 for the packaging and labeling of the coflex interlaminar technology; 11911 clark street, arcadia, ca 91006 for the laser marking, in-process cleaning, and inspection of the coflex interlaminar technology; and 1880 industrial drive, libertyville, il 60048 for the sterilization of the coflex interlaminar technology.
| Device | COFLEX® INTERLAMINAR TECHNOLOGY |
| Generic Name | Prosthesis, Spinous Process Spacer/plate |
| Applicant | RTI Surgical, Inc |
| Date Received | 2016-03-09 |
| Decision Date | 2016-08-23 |
| PMA | P110008 |
| Supplement | S005 |
| Product Code | NQO |
| Advisory Committee | Orthopedic |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Location Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | RTI Surgical, Inc 5600 Rowland Road, Suite 200 minnetonka, MN 55343 |
| 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 |