FDA applicant
Biomet Spine
FDA records 23 decisions for Biomet Spine (Parsippany, NJ) from 2007 to 2016: 23 510(k) clearances. Most are in product codes NKB (Thoracolumbosacral Pedicle Screw System) and MAX (Intervertebral Fusion Device With Bone Graft…). Its devices cite 75 predicates, 6 of them its own earlier devices. 7 recalls are linked to its devices.
FDA’s records also spell it “Biomet Spine, LLC”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Biomet Spine’s devices, and how often a recall has named them.
FDA decisions per year
2in 2016
2026 so far, outlined.
Recalls per year
1in 2018
Class I Class II/III not classified
Planning a device like Biomet 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 “Biomet”
FDA records each applicant name separately; these may or may not be the same firm.