KYPHON (R) HV-R(R) Bone Cement— 510(k) K150460

Substantially Equivalent

Medtronic Sofamor Danck USA, Inc.

FDA 510(k) clearance K150460 for KYPHON (R) HV-R(R) Bone Cement, Substantially Equivalent on 2015-04-28. Applicant: Medtronic Sofamor Danck USA, Inc..

Clearance details

Applicant: Medtronic Sofamor Danck USA, Inc.
Product code: Code NDN
Advisory panel: Orthopedic
Date received: 2015-02-23
Decision date: 2015-04-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, 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.