PASS LP SPINAL— 510(k) K112736

Substantially Equivalent

Medicrea International

FDA 510(k) clearance K112736 for PASS LP SPINAL, Substantially Equivalent on 2012-02-01. Applicant: Medicrea International.

Clearance details

Applicant: Medicrea International
Product code: Code JDQ
Advisory panel: Orthopedic
Date received: 2011-09-20
Decision date: 2012-02-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Round Rock, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JDQ

product code JDQ

Death: 9
Injury: 330
Total: 339

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.