KYPHX HV-R, MODEL C01A— 510(k) K033801

Substantially Equivalent

Kyphon, Inc.

FDA 510(k) clearance K033801 for KYPHX HV-R, MODEL C01A, Substantially Equivalent on 2004-04-01. Applicant: Kyphon, Inc..

Clearance details

Applicant: Kyphon, Inc.
Product code: Code NDN
Advisory panel: Orthopedic
Date received: 2003-12-08
Decision date: 2004-04-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

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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.