FDA applicant
X-Spine Systems, Inc.
FDA records 35 decisions for X-Spine Systems, Inc. (Miamisburg, OH) from 2004 to 2018: 35 510(k) clearances. Most are in product codes KWQ (Appliance, Fixation, Spinal Intervertebral Body) and ODP (Intervertebral Fusion Device With Bone Graft…). Since 2016 its 510(k)s took a median of 101 days from receipt to decision, against 110 for FDA’s reviews in the same codes and years. Its devices cite 75 predicates, 25 of them its own earlier devices. 14 recalls are linked to its devices.
FDA’s records also spell it “X-Spine Systems”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided X-Spine Systems, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2018
2026 so far, outlined.
Recalls per year
1in 2026
Class I Class II/III not classified
Planning a device like X-Spine Systems, 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