J-SCOPE SYSTEM— 510(k) K122411

Substantially Equivalent

Myelotec

FDA 510(k) clearance K122411 for J-SCOPE SYSTEM, Substantially Equivalent on 2013-02-11. Applicant: Myelotec.

Clearance details

Applicant: Myelotec
Product code: Code HRX
Advisory panel: Orthopedic
Date received: 2012-08-08
Decision date: 2013-02-11
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Mt. Airy, MD, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HRX

product code HRX

Injury: 623
Malfunction: 11,257
Total: 11,880

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.