510(k) Report

FDA applicant

Trinity Orthopedics, LLC

San Diego, CA2 decisions2007–20080 recalls

FDA records 2 decisions for Trinity Orthopedics, LLC (San Diego, CA) from 2007 to 2008: 2 510(k) clearances. All are in product code MNI (Orthosis, Spinal Pedicle Fixation). Its devices cite 10 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, last Nov 3, 2026

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

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

FDA decisions per year

1in 2008

2007: 12008: 1
2007high 1 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Trinity”

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