The following data is part of a premarket notification filed by Choicespine, Llc with the FDA for 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 .
| Device ID | K191621 |
| 510k 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 |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | ChoiceSpine, LLC 400 Erin Drive Knoxville, TN 37919 |
| Contact | Kim Finch |
| Correspondent | Kim Finch ChoiceSpine, LLC 400 Erin Drive Knoxville, TN 37919 |
| Product Code | ODP |
| Subsequent Product Code | MAX |
| Subsequent Product Code | OVE |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-18 |
| Decision Date | 2019-08-15 |