FDA Device Intelligence
Home › Jiangsu Changmei Medtech Co., Ltd. › Kyphoplasty Tool Kit

Kyphoplasty Tool Kit

Jiangsu Changmei Medtech Co., Ltd. · Model KT-00-06 · UDI-DI 06923558509693

OCJOARKIHLXH Prescription
1
510(k) clearances
20
Adverse events
2
Recalls
48
Facilities

Description

Kyphoplasty Tool Kit (Unilateral standard)

Recalls

DateFirmReason
2011-03-22DePuy Spine, Inc.Mislabeled: Package labeled (11g x 6 inch) contains a 13g x 4-inch side hole needle
2011-03-22DePuy Spine, Inc.Mislabeled: Package labeled (11g x 6 inch) contains a 13g x 4-inch side hole needle

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.