Response BandLoc Spinal Fixation— 510(k) K200097

Substantially Equivalent

OrthoPediatrics Corp.

FDA 510(k) clearance K200097 for Response BandLoc Spinal Fixation, Substantially Equivalent on 2020-03-16. Applicant: OrthoPediatrics Corp..

Clearance details

Applicant
OrthoPediatrics Corp.
Product code
Code OWI
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Warsaw, IN, US
Download summary PDFView on FDA.gov ↗

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