Altapore Shape— 510(k) K191513

Substantially Equivalent

Baxter Healthcare Corporation

FDA 510(k) clearance K191513 for Altapore Shape, Substantially Equivalent on 2019-10-19. Applicant: Baxter Healthcare Corporation.

Clearance details

Applicant: Baxter Healthcare Corporation
Product code: Code MQV
Advisory panel: Orthopedic
Date received: 2019-06-07
Decision date: 2019-10-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Round Lake, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MQV

product code MQV

Death: 6
Injury: 435
Total: 441

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.