Class Class II

Kyphoplasty Balloon Dilatation Catheters (K252458)

K252458 2025-11-03 Traditional
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Description

Kyphoplasty Balloon Dilatation Catheters by Shanghai Lange Medtech Co., Ltd., an FDA 510(k) cleared orthopedic device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK252458
Clearance Date2025-11-03
Clearance TypeTraditional
Product CodeHRX
Regulation Number888.1100

Categories

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