ANAX 5.5 Spinal System— 510(k) K162189

Name: FDA 510(k) clearance K162189
Creator: U.S. Food and Drug Administration
Published: 2016-08-30

Substantially Equivalent

U&I Corporation

FDA 510(k) clearance K162189 for ANAX 5.5 Spinal System, Substantially Equivalent on 2016-08-30. Applicant: U&I Corporation. Device class: 2.

Clearance details

Applicant: U&I Corporation
Product code: Code MNH
Device class: Class 2
Regulation: 21 CFR 888.3070
Advisory panel: Orthopedic
Date received: 2016-08-04
Decision date: 2016-08-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Uijeongbu-Si, KR

Download summary PDF View on FDA.gov ↗

Recent devices under product code MNH

view all

K162066 — Reliance Spinal Screw System2016-12-02
K162801 — CastleLoc Spinal Fixation System2016-11-03
K162143 — FixxSure® X-Link2016-09-23
K161151 — Spinal fixation system2016-09-21
K151362 — HC Spinal System2016-05-05

More clearances from U&I Corporation

view all

K220147 — Aspiron S ACP System2022-02-16
K210573 — Velofix SA Cervical Cage2021-11-19
K183243 — Velofix TLIF Cage2019-07-10
K190067 — Velofix Interbody Fusion System2019-02-04
K190053 — SECULOK ACP System2019-02-01

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.