LMT BONE ANCHOR— 510(k) K953764

Name: FDA 510(k) clearance K953764
Creator: U.S. Food and Drug Administration
Published: 1995-08-25

Substantially Equivalent

Li Medical Technologies, Inc.

FDA 510(k) clearance K953764 for LMT BONE ANCHOR, Substantially Equivalent on 1995-08-25. Applicant: Li Medical Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Li Medical Technologies, Inc.
Product code: Code JDR
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 1995-08-11
Decision date: 1995-08-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shelton, CT, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code JDR

product code JDR

Injury: 726
Malfunction: 663
Other: 1
Total: 1,390

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.