FixxSure® X-Link— 510(k) K162143

Name: FDA 510(k) clearance K162143
Creator: U.S. Food and Drug Administration
Published: 2016-09-23

Substantially Equivalent

Innovasis, Inc.

FDA 510(k) clearance K162143 for FixxSure® X-Link, Substantially Equivalent on 2016-09-23. Applicant: Innovasis, Inc.. Device class: 2.

Clearance details

Applicant: Innovasis, Inc.
Product code: Code MNH
Device class: Class 2
Regulation: 21 CFR 888.3070
Advisory panel: Orthopedic
Date received: 2016-08-01
Decision date: 2016-09-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

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
K161151 — Spinal fixation system2016-09-21
K162189 — ANAX 5.5 Spinal System2016-08-30
K151362 — HC Spinal System2016-05-05

More clearances from Innovasis, Inc.

view all

K251073 — Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments)2025-07-23
K250182 — Innovasis Navigation Instruments2025-03-24
K241276 — Vector Pedicle Screw System2024-05-20
K231899 — HAtetracell-C Titanium Cervical IBF System2023-10-17
K223511 — Excella Navigation Instruments2023-05-02

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.