FDA applicant
Instrument Makar, Inc.
FDA records 28 decisions for Instrument Makar, Inc. (Okemos, MI) from 1979 to 2000: 28 510(k) clearances. Most are in product codes MAI (Fastener, Fixation, Biodegradable, Soft Tissue) and HWC (Screw, Fixation, Bone). 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 Instrument Makar, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Instrument Makar, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Instrument Makar, 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 “Instrument”
FDA records each applicant name separately; these may or may not be the same firm.