FDA applicant
Choice Spine, LLC
FDA records 10 decisions for Choice Spine, LLC (Knoxville, TN) from 2009 to 2023: 10 510(k) clearances. Most are in product codes ODP (Intervertebral Fusion Device With Bone Graft…) and MAX (Intervertebral Fusion Device With Bone Graft…). Since 2016 its 510(k)s took a median of 165 days from receipt to decision, against 92 for FDA’s reviews in the same codes and years. Its devices cite 32 predicates, 4 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Choice Spine, Llp”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Choice Spine, LLC’s devices, and how often a recall has named them.
FDA decisions per year
1in 2023
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2009.
Planning a device like Choice Spine, LLC’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Choice”
FDA records each applicant name separately; these may or may not be the same firm.