EMERGE MEDICAL SMALL AND LARGE NON-LOCKING FRAGMENT PLATE SYSTEM— 510(k) K133541

Name: FDA 510(k) clearance K133541
Creator: U.S. Food and Drug Administration
Published: 2014-01-28

Substantially Equivalent

Emerge Medical

FDA 510(k) clearance K133541 for EMERGE MEDICAL SMALL AND LARGE NON-LOCKING FRAGMENT PLATE SYSTEM, Substantially Equivalent on 2014-01-28. Applicant: Emerge Medical. Device class: 2.

Clearance details

Applicant: Emerge Medical
Product code: Code HRS
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2013-11-18
Decision date: 2014-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Denver, CO, US

Download summary PDF View on FDA.gov ↗

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K261647 — Tempo Plating System; Ultra Compression Screw System2026-09-03
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K260277 — MIKRON TRAUMA BONE PLATE& SCREW SYSTEM2026-08-13
K261511 — Xpert Ankle2026-07-28

More clearances from Emerge Medical

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K141347 — EMERGE MEDICAL IM NAIL SYSTEM2014-10-02
K140107 — EMERGE MEDICAL DISTAL RADIUS SET2014-03-13
K140098 — EMERGE MEDICAL SMALL FRAGMENT LOCKED PLATING SYSTEM2014-03-12
K140119 — EMERGE MEDICAL PERIARTICULAR AND LOCKING LARGE FRAGMENT SYSTEM2014-03-12
K133536 — EMERGE MEDICAL BONE PLATE SYSTEM2014-02-26

Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

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.