FDA applicant
Altus Partners, LLC
FDA records 18 decisions for Altus Partners, LLC (West Chester, PA) from 2013 to 2025: 18 510(k) clearances. Most are in product codes NKB (Thoracolumbosacral Pedicle Screw System) and MAX (Intervertebral Fusion Device With Bone Graft…). Since 2016 its 510(k)s took a median of 160 days from receipt to decision, against 96 for FDA’s reviews in the same codes and years. Its devices cite 53 predicates, 17 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Altus Partners”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Altus Partners, LLC’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 2013.
Planning a device like Altus Partners, 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) ReportOther applicant names beginning “Altus”
FDA records each applicant name separately; these may or may not be the same firm.