Achieve Partial Knee System - Porous Coated CoCrMo Femoral Component— 510(k) K251975

Substantially Equivalent

Ignite Orthomotion

FDA 510(k) clearance K251975 for Achieve Partial Knee System - Porous Coated CoCrMo Femoral Component, Substantially Equivalent on 2025-09-02. Applicant: Ignite Orthomotion.

Clearance details

Applicant
Ignite Orthomotion
Product code
Code NJD
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Winona Lake, IN, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.