KYPHX DIRECTIONAL INFLATABLE BONE TAMP, MODELS K16A AND K17A— 510(k) K032212

Substantially Equivalent

Kyphon, Inc.

FDA 510(k) clearance K032212 for KYPHX DIRECTIONAL INFLATABLE BONE TAMP, MODELS K16A AND K17A, Substantially Equivalent on 2003-09-15. Applicant: Kyphon, Inc..

Clearance details

Applicant: Kyphon, Inc.
Product code: Code HRX
Advisory panel: Orthopedic
Date received: 2003-07-21
Decision date: 2003-09-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

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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.