MCCONNELL REAMER GUIDE— 510(k) K885100

Name: FDA 510(k) clearance K885100
Creator: U.S. Food and Drug Administration
Published: 1989-01-13

Substantially Equivalent

Mcconnell Orthopedic

FDA 510(k) clearance K885100 for MCCONNELL REAMER GUIDE, Substantially Equivalent on 1989-01-13. Applicant: Mcconnell Orthopedic. Device class: 1.

Clearance details

Applicant: Mcconnell Orthopedic
Product code: Code HTO
Device class: Class 1
Regulation: 21 CFR 888.4540
Advisory panel: Orthopedic
Date received: 1988-12-12
Decision date: 1989-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dallas, TX, US

Download summary PDF View on FDA.gov ↗

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K910974 — MCCONNELL SHOULDER BRACE1991-03-21
K905564 — PREP AND OPERATING STAND1991-02-21
K905565 — LATERAL BUTTRESS SUPPORT1991-02-21
K871820 — MCCONNELL ORTHOPEDIC ANTERIOR TORSO-ARM SUPPORT1987-05-26
K871821 — MCCONNELL ORTHOPEDIC POSTERIOR BODY SUPPORT1987-05-26

Adverse events under product code HTO

product code HTO

Injury: 404
Malfunction: 20,305
Total: 20,709

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.