ORTHOPEDIC IMPLANT NAILS & PINS— 510(k) K850026

Name: FDA 510(k) clearance K850026
Creator: U.S. Food and Drug Administration
Published: 1985-05-20

Substantially Equivalent

Kirkstil Corp., Inc.

FDA 510(k) clearance K850026 for ORTHOPEDIC IMPLANT NAILS & PINS, Substantially Equivalent on 1985-05-20. Applicant: Kirkstil Corp., Inc.. Device class: 2.

Clearance details

Applicant: Kirkstil Corp., Inc.
Product code: Code HTY
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 1985-01-03
Decision date: 1985-05-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

Download summary PDF View on FDA.gov ↗

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K850024 — ORTHOPEDIC IMPLANT SCREWS1985-05-20
K850025 — ORTHOPEDIC IMPLANT PLATES1985-05-20

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.