GENERAL SPINAL SYSTEM— 510(k) K140229

Name: FDA 510(k) clearance K140229
Creator: U.S. Food and Drug Administration
Published: 2014-04-29

Substantially Equivalent

Tianjin Walkman Biomaterial Co., Ltd.

FDA 510(k) clearance K140229 for GENERAL SPINAL SYSTEM, Substantially Equivalent on 2014-04-29. Applicant: Tianjin Walkman Biomaterial Co., Ltd.. Device class: 2.

Clearance details

Applicant: Tianjin Walkman Biomaterial Co., Ltd.
Product code: Code MNI
Device class: Class 2
Regulation: 21 CFR 888.3070
Advisory panel: Orthopedic
Date received: 2014-01-30
Decision date: 2014-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code MNI

view all

K171497 — Mikron Spinal Fixation System2017-10-12
K160731 — LumFix Spinal Fixation Sytem2016-10-04
K151458 — Double Medical Universal Spine System2016-08-22
K153273 — MySpine Pedicle Screw Placement Guides - LP2016-06-29
K160124 — LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System2016-04-04

More clearances from Tianjin Walkman Biomaterial Co., Ltd.

view all

K132078 — METALLIC INTRAMEDULLARY NAIL SYSTEM2014-03-19
K131759 — METALLIC LOCKING COMPRESSION BONE PLATES AND SCREWS SYSTEM2013-08-08

Adverse events under product code MNI

product code MNI

Injury: 641
Total: 641

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.