FDA applicant
Biomet Spine (Aka Ebi, LLC)
FDA records 13 decisions for Biomet Spine (Aka Ebi, LLC) (Parsippany, NJ) from 2010 to 2014: 13 510(k) clearances. Most are in product codes NKB (Thoracolumbosacral Pedicle Screw System) and KWP (Appliance, Fixation, Spinal Interlaminal). Its devices cite 88 predicates, 8 of them its own earlier devices. 5 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Biomet Spine (Aka Ebi, LLC)’s devices, and how often a recall has named them.
FDA decisions per year
4in 2014
2026 so far, outlined.
Recalls per year
3in 2015
Class I Class II/III not classified
Planning a device like Biomet Spine (Aka Ebi, 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 “Biomet”
FDA records each applicant name separately; these may or may not be the same firm.