FDA applicant
Rti Biologics, Inc.
FDA records 3 decisions for Rti Biologics, Inc. (Alachua, FL) from 2008 to 2013: 3 510(k) clearances. All are in product code FTM (Mesh, Surgical). Its devices cite 1 predicate, 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 Rti Biologics, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2013
2008high 1 (2008) · low 0 (2010)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2008.
Planning a device like Rti Biologics, 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