Sterispine™ PS
Safe Orthopaedics
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3009509485 | 3009509485 | SAFE ORTHOPAEDICS SAS | 1 | N | 2026-01-01 | Zone Dactivite De Montepy 80 Rue De Montepy Fleurieux-Sur-L'Arbresle Rhone FR 69210 |
| 3009761545 | 3009761545 | Safe Orthopaedics, LLC | 1 | Y | 2020-04-25 | 1700 W Irving Park Rd Suite 303 Chicago IL US 60613 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 03760219910305 | STERISPINE PS - KITMCL440 | +33601042297 | a.bellakhdar@safeorthopaedics.com |
| 03760219912729 | STERISPINE PS - KITMFL530 | +33601042297 | a.bellakhdar@safeorthopaedics.com |
| 03760219912743 | STERISPINE PS - KITMFL535 | +33601042297 | a.bellakhdar@safeorthopaedics.com |
| 03760219912767 | STERISPINE PS - KITMFL540 | +33601042297 | a.bellakhdar@safeorthopaedics.com |
| 03760219912781 | STERISPINE PS - KITMFL545 | +33601042297 | a.bellakhdar@safeorthopaedics.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 136244 | 1965349968 | K182287 | MEDINAUT Plus | HRX | 2019-04-06 |
| 136244 | 1809634836 | K170528 | Sterispine™ PS | NKB | 2017-03-09 |
| 136244 | 1493520265 | K162531 | STERISPINE CC | OVE | 2016-12-29 |
| 136244 | 1084822022 | K151921 | STERISPINE PS | NKB | 2015-10-08 |
| 136244 | 1618717541 | K151756 | STERISPINE LC CAGE | MAX | 2015-08-21 |
| 136244 | 1761318576 | K151747 | STERISPINE PS | NKB | 2015-10-05 |
| 136244 | 1812310201 | K150092 | STERISPINE PS Pedicle Screw | NKB | 2015-02-10 |
| 136244 | 1365468683 | K140802 | STERISPINE PS | NKB | 2014-06-04 |
| 144328 | 1466621476 | K133893 | STERISPINE LC CAGE | MAX | 2014-03-14 |
| 136244 | 1466621476 | K133893 | STERISPINE LC CAGE | MAX | 2014-03-14 |
| 136244 | 1132106923 | K130632 | STERISPINE PS PEDICLE SCREW | NKB | 2013-05-03 |
| 136244 | 1580003224 | K122021 | STERISPINE LC CAGE | MAX | 2012-09-20 |
| 136244 | 2004658006 | K121299 | STERISPINEPS PEDICLE SCREW, STERISPINEPS ROD | NKB | 2012-07-30 |
| 136244 | 1146800904 | K112453 | STERISPINEPS PEDICLE SCREW | NKB | 2011-11-15 |
| 136244 | 1293559824 | ||||
| 136244 | 1510253131 | ||||
| 136244 | 1955251743 |
Safe Orthopaedics
SAFE ORTHOPAEDICS
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