AXYA, MODEL 3000 AXYZLOOP TITANIUM BONE ANCHOR— 510(k) K070773

Name: FDA 510(k) clearance K070773
Creator: U.S. Food and Drug Administration
Published: 2007-10-11

Substantially Equivalent

Axya Medical, Inc.

FDA 510(k) clearance K070773 for AXYA, MODEL 3000 AXYZLOOP TITANIUM BONE ANCHOR, Substantially Equivalent on 2007-10-11. 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: 2007-03-21
Decision date: 2007-10-11
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.