SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone Cement— 510(k) K211238

Substantially Equivalent

Stryker Instruments

FDA 510(k) clearance K211238 for SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone Cement, Substantially Equivalent on 2021-06-25. Applicant: Stryker Instruments.

Clearance details

Applicant: Stryker Instruments
Product code: Code NDN
Advisory panel: Orthopedic
Date received: 2021-04-26
Decision date: 2021-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Portage, MI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code NDN

product code NDN

Death: 24
Injury: 407
Malfunction: 1,975
Total: 2,406

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.