Choice Spine, LLC
Choice Spine, LLC appears in FDA public data with 0 recalls, 10 510(k) clearances, 9 FDA inspections, and 0 compliance actions on record. Its most recent FDA inspection ended on Nov 4, 2022 (No Action Indicated (NAI)). Its most recent 510(k) clearance was granted on Sep 14, 2023.
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Summary
- Total Recalls
- 0
- 510(k) Clearances
- 10
- Inspections
- 9
- Compliance Actions
- 0
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Nov 4, 2022 | Knoxville, TN | Devices | No Action Indicated (NAI) | 3005819474 |
| Sep 30, 2019 | Knoxville, TN | Biologics | Voluntary Action Indicated (VAI) | 3005819474 |
| Aug 10, 2017 | Knoxville, TN | Devices | No Action Indicated (NAI) | 3005819474 |
| Feb 22, 2016 | Knoxville, TN | Biologics | No Action Indicated (NAI) | 3005819474 |
| Sep 25, 2015 | Knoxville, TN | Devices | No Action Indicated (NAI) | 3005819474 |
| Oct 31, 2013 | Knoxville, TN | Biologics | No Action Indicated (NAI) | 3005819474 |
| Nov 6, 2012 | Knoxville, TN | Devices | Voluntary Action Indicated (VAI) | 3005819474 |
| Feb 23, 2012 | Knoxville, TN | Biologics | No Action Indicated (NAI) | 3005819474 |
| Sep 25, 2009 | Knoxville, TN | Biologics | No Action Indicated (NAI) | 3005819474 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K223869 | ChoiceSpine Blackhawk Ti Cervical Spacer System | Sep 14, 2023 |
| K220953 | ChoiceSpine TigerShark M, Modular Interbody System | Sep 13, 2022 |
| K220024 | ChoiceSpine Navigation System | Jul 6, 2022 |
| K211449 | Triton Sacroiliac Joint Fixation System | Aug 31, 2021 |
| K203311 | ChoiceSpine Blackhawk Ti Cervical Spacer System | May 10, 2021 |
| K203561 | ChoiceSpine Navigation System | Jan 4, 2021 |
| K201643 | ChoiceSpine Tiger Shark Cervical Spacer System | Dec 22, 2020 |
| K191621 | ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer System… | Aug 15, 2019 |
| K191367 | Harrier-SA Lumbar Interbody System | Jul 5, 2019 |
| K091531 | CHOICE SPINE CERVICAL INTERBODY SPACER SYSTEM CHOICE SPINE CERVICAL INTERBODY SPACER | Nov 2, 2009 |