KYPHON XPEDE BONE CEMENT— 510(k) K102397

Substantially Equivalent

Medtronic

FDA 510(k) clearance K102397 for KYPHON XPEDE BONE CEMENT, Substantially Equivalent on 2011-02-28. Applicant: Medtronic.

Clearance details

Applicant: Medtronic
Product code: Code NDN
Advisory panel: Orthopedic
Date received: 2010-08-24
Decision date: 2011-02-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, 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.