POWERPRO BATTERY SYSTEM— 510(k) K012320

Substantially Equivalent

Linvatec Corp.

FDA 510(k) clearance K012320 for POWERPRO BATTERY SYSTEM, Substantially Equivalent on 2001-10-19. Applicant: Linvatec Corp..

Clearance details

Applicant: Linvatec Corp.
Product code: Code HAB
Advisory panel: General, Plastic Surgery
Date received: 2001-07-23
Decision date: 2001-10-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Largo, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HAB

product code HAB

Injury: 283
Malfunction: 5,362
Total: 5,645

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.