AMS MAINSTAY UROLOGIC BONE ANCHOR— 510(k) K971332

Substantially Equivalent

American Medical Systems, Inc.

FDA 510(k) clearance K971332 for AMS MAINSTAY UROLOGIC BONE ANCHOR, Substantially Equivalent on 1997-07-09. Applicant: American Medical Systems, Inc..

Clearance details

Applicant: American Medical Systems, Inc.
Product code: Code MBI
Advisory panel: Orthopedic
Date received: 1997-04-10
Decision date: 1997-07-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minnetonka, MN, 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.