FDA applicant
Ballert Orthopedic Corp.
FDA records 2 decisions for Ballert Orthopedic Corp. (Mchenry, IL) from 1978 to 1979: 2 510(k) clearances. Most are in product codes HST (Apparatus, Traction, Non-Powered) and IPG (Shoe, Cast). 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 Ballert Orthopedic Corp.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Ballert Orthopedic Corp. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Ballert Orthopedic Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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