AXYA MEDICAL, INC. MODEL 1000 AXYALOOP BONE ANCHOR— 510(k) K003971

Substantially Equivalent

Axya Medical, Inc.

FDA 510(k) clearance K003971 for AXYA MEDICAL, INC. MODEL 1000 AXYALOOP BONE ANCHOR, Substantially Equivalent on 2001-03-21. Applicant: Axya Medical, Inc..

Clearance details

Applicant: Axya Medical, Inc.
Product code: Code MBI
Advisory panel: Orthopedic
Date received: 2000-12-22
Decision date: 2001-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beverly, MA, US

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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.