FDA 510(k) Applications Submitted by Allison Gecik
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K210483 |
02/19/2021 |
MOBIO Total Knee System |
b-ONE ORTHO, Corp. |
| K180446 |
02/20/2018 |
b-ONE Total Knee System |
b-One Ortho Corp. |
| K222431 |
08/11/2022 |
b-ONER MOBIO Total Knee System |
b-ONE ORTHO, Corp. |
| K202429 |
08/25/2020 |
Mobio Total Knee System |
b-One Ortho, Corp. |
| K212912 |
09/13/2021 |
OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture Anchors, OneFix Interference Screws, OneFix Cannula System |
b-ONE ORTHO, Corp |
| K202768 |
09/21/2020 |
KOSMO Femoral Stem |
b-One Ortho Corp. |
| K182705 |
09/27/2018 |
Juveno Hip System Femoral Stem, b-ONE Primary Acetabular System Cups |
b-ONE Ortho Corp. |
| K183025 |
11/01/2018 |
MOBIO Total Knee System Posterior Stabilized (PS and PS+) Tibial Inserts, MOBIO Total Knee System Patellar Component |
b-One Ortho Corp. |
| K213673 |
11/22/2021 |
b-ONE MOBIO Total Knee System |
b-ONE ORTHO, Corp. |
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