Spinal Elements Cerclage System— 510(k) K180728

Substantially Equivalent

Spinal Elements, Inc.

FDA 510(k) clearance K180728 for Spinal Elements Cerclage System, Substantially Equivalent on 2018-09-06. Applicant: Spinal Elements, Inc..

Clearance details

Applicant
Spinal Elements, Inc.
Product code
Code OWI
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Carlsbad, CA, US
Download summary PDFView on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.