FDA applicant
Life Spine, Inc.
FDA records 123 decisions for Life Spine, Inc. (Huntley, IL) from 2004 to 2026: 123 510(k) clearances. Most are in product codes MAX (Intervertebral Fusion Device With Bone Graft…) and NKB (Thoracolumbosacral Pedicle Screw System). Since 2016 its 510(k)s took a median of 89 days from receipt to decision, against 95 for FDA’s reviews in the same codes and years. Its devices cite 370 predicates, 208 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Life Spine”, “Life Spine, LLC”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Life Spine, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
3in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Life Spine, Inc.’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) Report