STARR FRAME STEINMANN PIN— 510(k) K082017

Name: FDA 510(k) clearance K082017
Creator: U.S. Food and Drug Administration
Published: 2008-10-10

Substantially Equivalent

Starr Frame, LLC

FDA 510(k) clearance K082017 for STARR FRAME STEINMANN PIN, Substantially Equivalent on 2008-10-10. Applicant: Starr Frame, LLC. Device class: 2.

Clearance details

Applicant: Starr Frame, LLC
Product code: Code HTY
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2008-07-16
Decision date: 2008-10-10
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Richardson, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HTY

view all

K262722 — Primal K-Wire (P99-193-1410)2026-08-28
K253325 — ZipToe Hammertoe Fusion System2025-12-29
K252657 — Impact PEEK Union Nail System2025-09-19
K250315 — RONAVIS FX (FX-001)2025-08-01
K251362 — PediFlex Flexible Nail System2025-06-24

Adverse events under product code HTY

product code HTY

Injury: 544
Total: 544

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.