ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEM— 510(k) K952495

Name: FDA 510(k) clearance K952495
Creator: U.S. Food and Drug Administration
Published: 1996-01-22

Substantially Equivalent

Orthopedic Systems, Inc.

FDA 510(k) clearance K952495 for ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEM, Substantially Equivalent on 1996-01-22. Applicant: Orthopedic Systems, Inc.. Device class: 1.

Clearance details

Applicant: Orthopedic Systems, Inc.
Product code: Code LXH
Device class: Class 1
Regulation: 21 CFR 888.4540
Advisory panel: Orthopedic
Date received: 1995-05-30
Decision date: 1996-01-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Union City, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LXH

product code LXH

Death: 11
Injury: 2,218
Malfunction: 31,318
Total: 33,547

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.