FDA applicant
Acuitive Technologies, Inc.
FDA records 7 decisions for Acuitive Technologies, Inc. (Alendale, NJ) from 2020 to 2024: 7 510(k) clearances. Most are in product codes MAI (Fastener, Fixation, Biodegradable, Soft Tissue) and MQV (Filler, Bone Void, Calcium Compound). Since 2016 its 510(k)s took a median of 202 days from receipt to decision, against 78 for FDA’s reviews in the same codes and years. Its devices cite 12 predicates, 9 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Acuitive Technologies”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Acuitive Technologies, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2020.
Planning a device like Acuitive Technologies, Inc.’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