# Choice Spine, LLC

- Location (FDA's records): Knoxville, TN
- FDA decisions: 10 (2009–2023): 10 510(k) clearances
- Names in FDA's records: Choice Spine, LLC (9); Choice Spine, Llp (1)
- Product codes: ODP (3), MAX (2), OLO (2), OVE (2), OUR (1)
- 510(k) review time since 2016: median 165 days, against 92 for FDA's reviews in the same codes and years (3 of 9 faster)
- Predicates its devices cite: 32 (4 its own); citations of its devices by later devices: 13 (4 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Choicespine, LP: 10 (https://510kreport.com/company/choicespine)
- Exactech, Inc.: 6 (https://510kreport.com/company/exactech)
- Medtronic Sofamor Danek USA, Inc.: 3 (https://510kreport.com/company/medtronic-sofamor-danek-usa)
- SI-BONE, Inc.: 1 (https://510kreport.com/company/si-bone)
- Orthofix, Inc.: 1 (https://510kreport.com/company/orthofix)
- Synthes (Usa): 1 (https://510kreport.com/company/synthes-usa)
- Zyga Technology, Inc.: 1 (https://510kreport.com/company/zyga-technology)
- Genesys Spine: 1 (https://510kreport.com/company/genesys-spine)

## Firms that cite its devices most
- Spineart: 2 (https://510kreport.com/company/spineart)
- Nanovis, LLC: 1 (https://510kreport.com/company/nanovis)
- Spine Wave, Inc.: 1 (https://510kreport.com/company/spine-wave)
- Nexxt Spine, LLC: 1 (https://510kreport.com/company/nexxt-spine)
- Orthovita, Inc.: 1 (https://510kreport.com/company/orthovita)
- Choicespine, LP: 1 (https://510kreport.com/company/choicespine)
- Ctl Medical Corporation: 1 (https://510kreport.com/company/ctl-medical)
- Osseus Fusions Systems, LLC: 1 (https://510kreport.com/company/osseus-fusions-systems)

## Its most-cited devices
- K091531: Choice Spine Cervical Interbody Spacer System Choice Spine Cervical Interbody Spacer (2009), cited by 5
- K223869: ChoiceSpine Blackhawk Ti Cervical Spacer System (2023), cited by 2
- K203311: ChoiceSpine Blackhawk Ti Cervical Spacer System (2021), cited by 2
- K203561: ChoiceSpine Navigation System (2021), cited by 1
- K211449: Triton™ Sacroiliac Joint Fixation System (2021), cited by 1
- K201643: ChoiceSpine Tiger Shark Cervical Spacer System (2020), cited by 1

## Recent decisions
- 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 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 (Aug 15, 2019)

Source page: https://510kreport.com/company/choice-spine