AXYA MODEL 3000 AXYALOOP TITANIUM BONE ANCHOR SYSTEM— 510(k) K022207

Name: FDA 510(k) clearance K022207
Creator: U.S. Food and Drug Administration
Published: 2002-10-04

Substantially Equivalent

Axya Medical, Inc.

FDA 510(k) clearance K022207 for AXYA MODEL 3000 AXYALOOP TITANIUM BONE ANCHOR SYSTEM, Substantially Equivalent on 2002-10-04. 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: 2002-07-08
Decision date: 2002-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beverly, MA, US

Download summary PDF View on FDA.gov ↗

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K070773 — AXYA, MODEL 3000 AXYZLOOP TITANIUM BONE ANCHOR2007-10-11
K070253 — AXYA SUTURE WELDING SYSTEM AND KIT2007-07-11
K063194 — TUFFLEX POLYESTER SUTURE2006-12-04
K060165 — AXYAFLEX POLYESTER SUTURE2006-09-01
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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.