FDA applicant
Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics
FDA records 2 decisions for Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics (El Dorado Hills, CA) from 2025 to 2026: 2 510(k) clearances. Most are in product codes LPH (Prosthesis, Hip, Semi-Constrained…) and HSX (Prosthesis, Knee, Femorotibial…). Its devices cite 6 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
How often FDA has decided Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics’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 2025.
Planning a device like Shalby Advanced Technologies, Inc. Dba…’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 “Shalby”
FDA records each applicant name separately; these may or may not be the same firm.