To replace a broken coordinate measuring machine (cmm) used in the production of the star tibial, talar, and uhmwpe mobile bearing (also referred to as the ‘sliding cores’) components with another cmm (zeiss contura cmm) at the waldemar link contract manufacturing facility in germany
| Device | Scandinavian Total Ankle Replacment (STAR Ankle) |
| Generic Name | Prosthesis, Ankle, Uncemented, Non-constrained |
| Applicant | STRYKER CORPORATION |
| Date Received | 2020-12-14 |
| Decision Date | 2021-01-13 |
| PMA | P050050 |
| Supplement | S016 |
| Product Code | NTG |
| Advisory Committee | Orthopedic |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | STRYKER CORPORATION bohnackerweg 1 selzach CH 25 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P050050 | | Original Filing |
| S025 |
2022-09-02 |
30-day Notice |
| S024 | | |
| S023 | | |
| S022 |
2022-02-01 |
30-day Notice |
| S021 | | |
| S020 |
2021-11-19 |
Special (immediate Track) |
| S019 |
2021-07-09 |
Normal 180 Day Track No User Fee |
| S018 |
2021-03-24 |
30-day Notice |
| S017 |
2021-02-16 |
30-day Notice |
| S016 |
2020-12-14 |
30-day Notice |
| S015 |
2020-11-02 |
30-day Notice |
| S014 |
2020-08-03 |
30-day Notice |
| S013 | | |
| S012 |
2018-08-21 |
Real-time Process |
| S011 |
2017-10-10 |
Real-time Process |
| S010 |
2016-07-12 |
Real-time Process |
| S009 | | |
| S008 |
2016-04-11 |
Normal 180 Day Track No User Fee |
| S007 |
2014-03-11 |
Normal 180 Day Track No User Fee |
| S006 |
2014-03-10 |
Real-time Process |
| S005 |
2012-11-13 |
Special (immediate Track) |
| S004 |
2012-09-04 |
Normal 180 Day Track No User Fee |
| S003 | | |
| S002 |
2009-08-21 |
Normal 180 Day Track No User Fee |
| S001 |
2009-08-05 |
Normal 180 Day Track No User Fee |
NIH GUDID Devices