FDA applicant
Eit Emerging Implant Technologies GmbH
FDA records 5 decisions for Eit Emerging Implant Technologies GmbH (Wurmlingen, DE) from 2017 to 2020: 5 510(k) clearances. All are in product code MAX (Intervertebral Fusion Device With Bone Graft…). Since 2016 its 510(k)s took a median of 85 days from receipt to decision, against 116 for FDA’s reviews in the same codes and years. Its devices cite 16 predicates, 7 of them its own earlier devices. 2 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Eit Emerging Implant Technologies GmbH’s devices, and how often a recall has named them.
FDA decisions per year
1in 2020
2026 so far, outlined.
Recalls per year
2in 2022
Class I Class II/III not classified
Planning a device like Eit Emerging Implant Technologies GmbH’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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