CaP Spheres Pellet Pack— 510(k) K203218

Substantially Equivalent

Zimmer Biomet Spine, Inc.

FDA 510(k) clearance K203218 for CaP Spheres Pellet Pack, Substantially Equivalent on 2021-05-04. Applicant: Zimmer Biomet Spine, Inc..

Clearance details

Applicant: Zimmer Biomet Spine, Inc.
Product code: Code MQV
Advisory panel: Orthopedic
Date received: 2020-11-02
Decision date: 2021-05-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westminister, CO, 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.