FDA 510(k) Applications Submitted by Christina Rovaldi
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K200888 |
04/03/2020 |
OMNIBotics Knee System |
Corin Ltd. |
| K171156 |
04/20/2017 |
OMNI Anseris Hip Stem |
OMNIlife science |
| K201657 |
06/18/2020 |
Corin Ltd. Hip Products: TrinityÖ Acetabular System, TrinityÖ PLUS Acetabular Shell, MetaFixÖ Hip System, TriFitÖ CF and TS Hip Systems, TaperFitÖ Hip System, RevivalÖ Modular Hip System, MiniHipÖ, TrinityÖ Dual Mobility, MobiliT, BiPolar-i, OMNI MODÖ Hip |
Corin Ltd. |
| K191765 |
07/01/2019 |
OMNI TiN Coated Apex KneeÖ System |
OMNI life science, Inc. |
| K222390 |
08/08/2022 |
Flex-ThreadÖ Ulna Intramedullary Nail System |
Flower Orthopedics Corporation DBA Conventus Flower |
| K172467 |
08/15/2017 |
OMNI ARC Anteverted Neck Hip Stem |
OMNIlife science |
| K233567 |
11/06/2023 |
OsteoCoilÖ Nitinol Compression System (Multiple Component PNs) |
Flower Orthopedics Corporation DBA Conventus Flower Ortho |
| K153437 |
11/27/2015 |
Apex Revision Knee System |
OMNILIFE SCIENCE |
| K163332 |
11/28/2016 |
Apex Revision Knee System |
OMNIlife science |
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