510(k) Report

FDA applicant

Fla Orthopedics, Inc.

Miami Lakes, FL4 decisions1997–19970 recalls

FDA records 4 decisions for Fla Orthopedics, Inc. (Miami Lakes, FL) in 1997: 4 510(k) clearances. All are in product code FMQ (Restraint, Protective). 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, general hospital panel, where it files most

How often FDA has decided Fla Orthopedics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Fla Orthopedics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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