FDA applicant

Biomet Spine (Ebi, LLC)

Parsippany, NJ1 decision2011–20110 recalls

FDA records 1 decision for Biomet Spine (Ebi, LLC) (Parsippany, NJ) in 2011: 1 510(k) clearance. All are in product code NKB (Thoracolumbosacral Pedicle Screw System). Its devices cite 3 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

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 Spine (Ebi, LLC)’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Biomet Spine (Ebi, LLC) by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Biomet Spine (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) Report

Other applicant names beginning “Biomet”

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

Biomet, Inc. 446 Biomet Manufacturing Corp 129 Biomet Orthopedics, Inc. 41 Biomet 3i, Inc. 32 Biomet Microfixation 31 Biomet Spine 23 Biomet Sports Medicine 13 Biomet Spine (Aka Ebi, LLC) 13 Biomet Trauma 7 Biomet Trauma (Aka Ebi, Lp) 4 Biomet Micofixation 3 Biomet UK, Ltd. 3

Biomet Spine (Ebi, LLC)

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Biomet”