510(k) Report

FDA applicant

Instrument Makar, Inc.

Okemos, MI28 decisions1979–20000 recalls

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, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

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.

FIG. 1 — Instrument Makar, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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.

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Other applicant names beginning “Instrument”

FDA records each applicant name separately; these may or may not be the same firm.