KYPHX INFLATABLE BONE TAMP, SIZE 20/3,MODEL K01A, KYPHX INFLATABLE BONE TAMP, SIZE 15/3, MODEL K02A— 510(k) K010246

Substantially Equivalent

Kyphon, Inc.

FDA 510(k) clearance K010246 for KYPHX INFLATABLE BONE TAMP, SIZE 20/3,MODEL K01A, KYPHX INFLATABLE BONE TAMP, SIZE 15/3, MODEL K02A, Substantially Equivalent on 2001-02-14. Applicant: Kyphon, Inc..

Clearance details

Applicant: Kyphon, Inc.
Product code: Code HRX
Advisory panel: Orthopedic
Date received: 2001-01-26
Decision date: 2001-02-14
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.