FDA applicant
Spectrum Spine, LLC
FDA records 8 decisions for Spectrum Spine, LLC (Jasper, GA) from 2013 to 2026: 8 510(k) clearances. Most are in product codes MAX (Intervertebral Fusion Device With Bone Graft…) and ODP (Intervertebral Fusion Device With Bone Graft…). Since 2016 its 510(k)s took a median of 223 days from receipt to decision, against 97 for FDA’s reviews in the same codes and years. Its devices cite 30 predicates, 9 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Spectrum Spine, Inc.”, “Spectrum Spine”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Spectrum Spine, LLC’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2013.
Planning a device like Spectrum 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 “Spectrum”
FDA records each applicant name separately; these may or may not be the same firm.