PRESSON SPINAL FIXATION SYSTEM— 510(k) K133287

Name: FDA 510(k) clearance K133287
Creator: U.S. Food and Drug Administration
Published: 2014-02-25

Substantially Equivalent

Nexus Spine, LLC

FDA 510(k) clearance K133287 for PRESSON SPINAL FIXATION SYSTEM, Substantially Equivalent on 2014-02-25. Applicant: Nexus Spine, LLC. Device class: 2.

Clearance details

Applicant: Nexus Spine, LLC
Product code: Code MNH
Device class: Class 2
Regulation: 21 CFR 888.3070
Advisory panel: Orthopedic
Date received: 2013-10-25
Decision date: 2014-02-25
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
K162143 — FixxSure® X-Link2016-09-23
K161151 — Spinal fixation system2016-09-21
K162189 — ANAX 5.5 Spinal System2016-08-30

More clearances from Nexus Spine, LLC

view all

K243934 — Stable-L Lumbar Interbody System2025-04-30
K241467 — Stable-C Interbody System2024-07-17
K233375 — Tranquil-L Interbody System2024-03-20
K240416 — Tranquil-C Interbody System2024-03-12
K233234 — PressON Spinal Fixation System2023-10-26

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.