FDA applicant
Ebi, L.P.
FDA records 104 decisions for Ebi, L.P. (Parsippany, NJ) from 1983 to 2020: 103 510(k) clearances and 1 original PMA approval. Most are in product codes KTT (Appliance, Fixation, Nail/Blade/Plate…) and NKB (Thoracolumbosacral Pedicle Screw System). Its devices cite 187 predicates, 63 of them its own earlier devices. 23 recalls are linked to its devices.
FDA’s records also spell it “Ebi, LLC”, “Ebi, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Ebi, L.P.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2020
2026 so far, outlined.
Recalls per year
1in 2020
Class I Class II/III not classified
Planning a device like Ebi, L.P.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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