510(k) Report

FDA applicant

R. Thomas Grotz, M.D., Inc.

San Francisco, CA4 decisions1997–19990 recalls

FDA records 4 decisions for R. Thomas Grotz, M.D., Inc. (San Francisco, CA) from 1997 to 1999: 4 510(k) clearances. Most are in product codes MBI (Fastener, Fixation, Nondegradable, Soft Tissue) and MRI (Orthosis, Truncal/Orthosis, Limb). Its devices cite 3 predicates, 3 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 R. Thomas Grotz, M.D., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for R. Thomas Grotz, M.D., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — R. Thomas Grotz, M.D., Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like R. Thomas Grotz, M.D., 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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