SPINAL MARKER— 510(k) K944188

Name: FDA 510(k) clearance K944188
Creator: U.S. Food and Drug Administration
Published: 1995-04-13

Substantially Equivalent

Leibinger L.P.

FDA 510(k) clearance K944188 for SPINAL MARKER, Substantially Equivalent on 1995-04-13. Applicant: Leibinger L.P.. Device class: 1.

Clearance details

Applicant: Leibinger L.P.
Product code: Code LXH
Device class: Class 1
Regulation: 21 CFR 888.4540
Advisory panel: Orthopedic
Date received: 1994-08-26
Decision date: 1995-04-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dallas, TX, US

Download summary PDF View on FDA.gov ↗

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K952495 — ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEM1996-01-22

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.