AMSET R-F SYSTEM— 510(k) K951266

Substantially Equivalent for Some Indications

Advanced Spine Technology, Inc.

FDA 510(k) clearance K951266 for AMSET R-F SYSTEM, Substantially Equivalent for Some Indications on 1995-11-21. Applicant: Advanced Spine Technology, Inc..

Clearance details

Applicant: Advanced Spine Technology, Inc.
Product code: Code MNH
Advisory panel: Orthopedic
Date received: 1995-03-21
Decision date: 1995-11-21
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Hayward, CA, US

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Adverse events under product code MNH

product code MNH

Injury: 978
Malfunction: 793
Total: 1,771

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.