FDA applicant
Generation II Orthotics, Inc.
FDA records 1 decision for Generation II Orthotics, Inc. (Mchenry, IL) in 1981: 1 510(k) clearance. All are in product code ITM (Cage, Knee). 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 Generation II Orthotics, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Generation II Orthotics, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Generation II Orthotics, 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