Choice Spine, LLC · Class II · Cleared Aug 15, 2019
| K-number | K191621 |
| Device name | 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 Octane Straight, ChoiceSpine Intervertebral Fusion Device Octane Straight PC, ChoiceSpine VEO Laterial Access & Interbody Fusion System |
| Applicant | Choice Spine, LLC |
| Product code | ODP |
| Device class | Class II |
| Decision date | Aug 15, 2019 |
| Decision | Substantially Equivalent |
| Regulation | 888.3080 |
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