510(k) Report

FDA applicant

Biomet Trauma (Aka Ebi, Lp)

Parsippany, NJ4 decisions2010–20110 recalls

FDA records 4 decisions for Biomet Trauma (Aka Ebi, Lp) (Parsippany, NJ) from 2010 to 2011: 4 510(k) clearances. Most are in product codes HRS (Plate, Fixation, Bone) and KTT (Appliance, Fixation, Nail/Blade/Plate…). Its devices cite 18 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Biomet Trauma (Aka Ebi, LLC)”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided Biomet Trauma (Aka Ebi, Lp)’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2010: 32011: 1
2010high 3 (2010) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Biomet Trauma (Aka Ebi, Lp) by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Biomet”

FDA records each applicant name separately; these may or may not be the same firm.