Spinal fixation system— 510(k) K161151

Name: FDA 510(k) clearance K161151
Creator: U.S. Food and Drug Administration
Published: 2016-09-21

Substantially Equivalent

Canwell Medical Co., Ltd.

FDA 510(k) clearance K161151 for Spinal fixation system, Substantially Equivalent on 2016-09-21. Applicant: Canwell Medical Co., Ltd.. Device class: 2.

Clearance details

Applicant: Canwell Medical Co., Ltd.
Product code: Code MNH
Device class: Class 2
Regulation: 21 CFR 888.3070
Advisory panel: Orthopedic
Date received: 2016-04-25
Decision date: 2016-09-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jinhua, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code MNH

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K162066 — Reliance Spinal Screw System2016-12-02
K162801 — CastleLoc Spinal Fixation System2016-11-03
K162143 — FixxSure® X-Link2016-09-23
K162189 — ANAX 5.5 Spinal System2016-08-30
K151362 — HC Spinal System2016-05-05

More clearances from Canwell Medical Co., Ltd.

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K242973 — CanMINI Hand and Foot System2025-04-24
K142943 — Metallic Locking Bone Plate and Screw2015-08-03

Adverse events under product code MNH

product code MNH

Injury: 978
Malfunction: 793
Total: 1,771

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.