MODEL 2000 AXYALOOP SELF-TAPPING BONE ANCHOR, MODEL 2000— 510(k) K011912

Name: FDA 510(k) clearance K011912
Creator: U.S. Food and Drug Administration
Published: 2001-08-31

Substantially Equivalent

Axya Medical, Inc.

FDA 510(k) clearance K011912 for MODEL 2000 AXYALOOP SELF-TAPPING BONE ANCHOR, MODEL 2000, Substantially Equivalent on 2001-08-31. Applicant: Axya Medical, Inc.. Device class: 2.

Clearance details

Applicant: Axya Medical, Inc.
Product code: Code MBI
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2001-06-19
Decision date: 2001-08-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beverly, MA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MBI

product code MBI

Injury: 3,163
Malfunction: 13,006
Other: 2
Total: 16,171

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.