BAUMER PINS— 510(k) K930969

Name: FDA 510(k) clearance K930969
Creator: U.S. Food and Drug Administration
Published: 1994-03-29

Substantially Equivalent

Baumer Ortopedia , Ltd.

FDA 510(k) clearance K930969 for BAUMER PINS, Substantially Equivalent on 1994-03-29. Applicant: Baumer Ortopedia , Ltd.. Device class: 2.

Clearance details

Applicant: Baumer Ortopedia , Ltd.
Product code: Code HTY
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 1993-02-24
Decision date: 1994-03-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mogi Mirim-Sp-Brasil, BR

Download summary PDF View on FDA.gov ↗

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K930966 — BAUMER PLATES1994-04-25
K930972 — INTRAMEDULLARY SYSTEMS1994-03-29
K930967 — BAUMER STAPLES1994-03-07
K930970 — BAUMER SCREWS1994-01-07

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.