OGDEN ANCHOR FOR ALL ORTHOPAEDIC SOFT TISSUE APPLICATIONS— 510(k) K951545

Name: FDA 510(k) clearance K951545
Creator: U.S. Food and Drug Administration
Published: 1995-07-03

Substantially Equivalent

American Medical Electronics, Inc.

FDA 510(k) clearance K951545 for OGDEN ANCHOR FOR ALL ORTHOPAEDIC SOFT TISSUE APPLICATIONS, Substantially Equivalent on 1995-07-03. Applicant: American Medical Electronics, Inc.. Device class: 2.

Clearance details

Applicant: American Medical Electronics, Inc.
Product code: Code HWC
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 1995-03-30
Decision date: 1995-07-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Richardson, TX, US

Download summary PDF View on FDA.gov ↗

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More clearances from American Medical Electronics, Inc.

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K951232 — EXPANDED RANGE OF SUTURE SIZES OGDEN ANCHORS: 7.4MM AND 5.5MM1995-08-25
K952348 — OGDEN ANCHOR1995-08-21
K950875 — OGDEN ANCHOR1995-07-11
K951493 — OGDEN ANCHOR1995-07-03
K941029 — OGDEN ANCHOR-SMALL (TENTATIVE)1995-02-09

Adverse events under product code HWC

product code HWC

Death: 20
Injury: 15,910
Malfunction: 8,192
Other: 1
Total: 24,123

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.