KYPHON ELEMENT Inflatable Bone Tamp— 510(k) K151532

Substantially Equivalent

Medtronic, Inc.

FDA 510(k) clearance K151532 for KYPHON ELEMENT Inflatable Bone Tamp, Substantially Equivalent on 2015-07-23. Applicant: Medtronic, Inc..

Clearance details

Applicant: Medtronic, Inc.
Product code: Code HRX
Advisory panel: Orthopedic
Date received: 2015-06-08
Decision date: 2015-07-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HRX

product code HRX

Injury: 623
Malfunction: 11,257
Total: 11,880

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.