BAUMER PLATES— 510(k) K930966

Name: FDA 510(k) clearance K930966
Creator: U.S. Food and Drug Administration
Published: 1994-04-25

Substantially Equivalent

Baumer Ortopedia , Ltd.

FDA 510(k) clearance K930966 for BAUMER PLATES, Substantially Equivalent on 1994-04-25. Applicant: Baumer Ortopedia , Ltd.. Device class: 2.

Clearance details

Applicant: Baumer Ortopedia , Ltd.
Product code: Code HRS
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 1993-02-24
Decision date: 1994-04-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mogi Mirim-Sp-Brasil, BR

Download summary PDF View on FDA.gov ↗

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K260277 — MIKRON TRAUMA BONE PLATE& SCREW SYSTEM2026-08-13
K261511 — Xpert Ankle2026-07-28

More clearances from Baumer Ortopedia , Ltd.

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K930969 — BAUMER PINS1994-03-29
K930972 — INTRAMEDULLARY SYSTEMS1994-03-29
K930967 — BAUMER STAPLES1994-03-07
K930970 — BAUMER SCREWS1994-01-07

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.