FDA 510(k) Applications Submitted by Emmarie Halteman
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K190959 |
04/12/2019 |
ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with TiONIC Technology |
Medtronic Sofamor Danek USA, Inc |
| K192502 |
09/12/2019 |
Anatomic PEEKÖ Cervical Fusion System, Anatomic PEEKÖ PTC Cervical Fusion System, CapstoneÖ Spinal System, Capstone PTCÖ Spinal System, Capstone ControlÖ Spinal System, Capstone Control PTCÖ Spinal System, ClydesdaleÖ Spinal System, Clydesdale PTCÖ Spinal |
Medtronic Sofamor Danek USA, Inc |
| K243344 |
10/25/2024 |
Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures |
Arthrex Inc. |
| K233971 |
12/15/2023 |
Arthrex AlloSync PushLock Suture Anchor |
Arthrex, Inc. |
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