KYPHX XPANDER INFLATABLE BONE TAMPS MODEL#KO8A,KO9A,K13A— 510(k) K041454

Substantially Equivalent

Kyphon, Inc.

FDA 510(k) clearance K041454 for KYPHX XPANDER INFLATABLE BONE TAMPS MODEL#KO8A,KO9A,K13A, Substantially Equivalent on 2004-07-09. Applicant: Kyphon, Inc..

Clearance details

Applicant: Kyphon, Inc.
Product code: Code HRX
Advisory panel: Orthopedic
Date received: 2004-06-01
Decision date: 2004-07-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, 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.