FDA 510(k) Applications Submitted by ChoiceSpine, LLC
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K220024 |
01/05/2022 |
ChoiceSpine Navigation System |
ChoiceSpine, LLC |
| K220953 |
04/01/2022 |
ChoiceSpine TigerSharkÖ M, Modular Interbody System |
ChoiceSpine, LLC |
| K211449 |
05/10/2021 |
TritonÖ Sacroiliac Joint Fixation System |
ChoiceSpine, LLC |
| K201643 |
06/17/2020 |
ChoiceSpine Tiger Shark Cervical Spacer System |
ChoiceSpine, LLC |
| K191621 |
06/18/2019 |
ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer System Ascendant PC, ChoiceSpine Cervical Interbody Spacer System Ascendant, ChoiceSpine Cervical Spacer System Blackhawk, ChoiceSpine Intervertebral Fusion Device Octan |
ChoiceSpine, LLC |
| K203311 |
11/10/2020 |
ChoiceSpine Blackhawk Ti Cervical Spacer System |
ChoiceSpine, LLC |
| K203561 |
12/07/2020 |
ChoiceSpine Navigation System |
ChoiceSpine, LLC |
| K223869 |
12/23/2022 |
ChoiceSpine Blackhawk Ti Cervical Spacer System |
ChoiceSpine, LLC |
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