ANSPACH MINIMAL ACCESS SPINAL ATTACHMENT (MASA) SYSTEM— 510(k) K042783

Substantially Equivalent

The Anspach Effort, Inc.

FDA 510(k) clearance K042783 for ANSPACH MINIMAL ACCESS SPINAL ATTACHMENT (MASA) SYSTEM, Substantially Equivalent on 2004-12-17. Applicant: The Anspach Effort, Inc..

Clearance details

Applicant: The Anspach Effort, Inc.
Product code: Code HBE
Advisory panel: Neurology
Date received: 2004-10-06
Decision date: 2004-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palm Beach Gardens, FL, US

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Adverse events under product code HBE

product code HBE

Injury: 306
Malfunction: 7,175
Other: 1
Total: 7,482

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.