FDA applicant
Mikron Makina Sanayi VE Ticaret Ltd. Sti.
FDA records 3 decisions for Mikron Makina Sanayi VE Ticaret Ltd. Sti. (Chesapeake City, MD) from 2013 to 2024: 3 510(k) clearances. Most are in product codes MNI (Orthosis, Spinal Pedicle Fixation) and NKB (Thoracolumbosacral Pedicle Screw System). Its devices cite 8 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 Mikron Makina Sanayi VE Ticaret Ltd. Sti.’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 2013.
Planning a device like Mikron Makina Sanayi VE Ticaret Ltd.…’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 “Mikron”
FDA records each applicant name separately; these may or may not be the same firm.