JGH1 Bone Graft Substitute— 510(k) K181342

Substantially Equivalent

AgNovos Healthcare USA, LLC

FDA 510(k) clearance K181342 for JGH1 Bone Graft Substitute, Substantially Equivalent on 2018-07-19. Applicant: AgNovos Healthcare USA, LLC.

Clearance details

Applicant: AgNovos Healthcare USA, LLC
Product code: Code MQV
Advisory panel: Orthopedic
Date received: 2018-05-21
Decision date: 2018-07-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockville, MD, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MQV

product code MQV

Death: 6
Injury: 435
Total: 441

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.