510(k) Report

FDA applicant

Renovo Life, LLC

Belmont, NC2 decisions2016–20160 recalls

FDA records 2 decisions for Renovo Life, LLC (Belmont, NC) in 2016: 2 510(k) clearances. Most are in product codes HSB (Rod, Fixation, Intramedullary And Accessories) and HTW (Bit, Drill). Its devices cite 3 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 Renovo Life, LLC’s devices, and how often a recall has named them.

FDA decisions per year

2in 2016

2016: 2
2016high 2 (2016) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Renovo Life, LLC by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Renovo”

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