FDA applicant
Synthes Spine
FDA records 54 decisions for Synthes Spine (West Chester, PA) from 1995 to 2012: 54 510(k) clearances. Most are in product codes KWQ (Appliance, Fixation, Spinal Intervertebral Body) and NKB (Thoracolumbosacral Pedicle Screw System). Its devices cite 177 predicates, 60 of them its own earlier devices. 19 recalls are linked to its devices, 1 Class I.
FDA’s records also spell it “Synthes Spine Co.Lp”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Synthes Spine’s devices, and how often a recall has named them.
FDA decisions per year
7in 2012
2026 so far, outlined.
Recalls per year
1in 2020
Class I Class II/III not classified
Planning a device like Synthes Spine’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 “Synthes”
FDA records each applicant name separately; these may or may not be the same firm.