IMSE Cervical Cage— 510(k) K162003

Substantially Equivalent

The Institute of Musculoskeletal Science & Education

FDA 510(k) clearance K162003 for IMSE Cervical Cage, Substantially Equivalent on 2016-12-21. Applicant: The Institute of Musculoskeletal Science & Education.

Clearance details

Applicant
The Institute of Musculoskeletal Science & Education
Product code
Code ODP
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Wayne, PA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code ODP

product code ODP
Injury
310
Total
310

Source: openFDA MAUDE database, through . 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.