SPONDY SPINAL FIXATION SYSTEM— 510(k) K100956

Substantially Equivalent

Allure Spine LLC

FDA 510(k) clearance K100956 for SPONDY SPINAL FIXATION SYSTEM, Substantially Equivalent on 2010-07-09. Applicant: Allure Spine LLC.

Clearance details

Applicant: Allure Spine LLC
Product code: Code MNH
Advisory panel: Orthopedic
Date received: 2010-04-07
Decision date: 2010-07-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Charlotte, NC, US

Download summary PDF View on FDA.gov ↗

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.