FDA applicant
Foundation Surgical Group, Inc.
FDA records 5 decisions for Foundation Surgical Group, Inc. (Scottsdale, AZ) from 2024 to 2026: 5 510(k) clearances. Most are in product codes MQP (Spinal Vertebral Body Replacement Device) and OVD (Intervertebral Fusion Device With Integrated…). Since 2016 its 510(k)s took a median of 104 days from receipt to decision, against 109 for FDA’s reviews in the same codes and years. Its devices cite 13 predicates, 2 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Foundation Surgical Group”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Foundation Surgical Group, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2024.
Planning a device like Foundation Surgical Group, 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) ReportOther applicant names beginning “Foundation”
FDA records each applicant name separately; these may or may not be the same firm.