SELECTIVE-AXIS POSTERIOR NONCERVICAL PLATING SYSTEM— 510(k) K051697

Name: FDA 510(k) clearance K051697
Creator: U.S. Food and Drug Administration
Published: 2005-09-21

Substantially Equivalent

Medical Device Advisory Development Group

FDA 510(k) clearance K051697 for SELECTIVE-AXIS POSTERIOR NONCERVICAL PLATING SYSTEM, Substantially Equivalent on 2005-09-21. Applicant: Medical Device Advisory Development Group. Device class: 2.

Clearance details

Applicant: Medical Device Advisory Development Group
Product code: Code MNH
Device class: Class 2
Regulation: 21 CFR 888.3070
Advisory panel: Orthopedic
Date received: 2005-06-23
Decision date: 2005-09-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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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

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.