FDA applicant
Zsfab, Inc.
FDA records 8 decisions for Zsfab, Inc. (Waltham, MA) from 2021 to 2026: 8 510(k) clearances. Most are in product codes ODP (Intervertebral Fusion Device With Bone Graft…) and MAX (Intervertebral Fusion Device With Bone Graft…). Since 2016 its 510(k)s took a median of 78 days from receipt to decision, against 90 for FDA’s reviews in the same codes and years. Its devices cite 19 predicates, 10 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “ZSFab, Inc.”, “Zsfab”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Zsfab, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2021.
Planning a device like Zsfab, 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