ACHIEVE Partial Knee System— 510(k) K242307

Substantially Equivalent

Ignite Orthomotion

FDA 510(k) clearance K242307 for ACHIEVE Partial Knee System, Substantially Equivalent on 2024-12-16. Applicant: Ignite Orthomotion. Device class: 2.

Clearance details

Applicant: Ignite Orthomotion
Product code: Code NJD
Device class: Class 2
Regulation: 21 CFR 888.3535
Advisory panel: Orthopedic
Date received: 2024-08-05
Decision date: 2024-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Winona Lake, IN, US

Download summary PDF View on FDA.gov ↗

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K190439 — Engage Partial Knee System2019-11-21
K133811 — RESTORIS POROUS PARTIAL KNEE SYSTEM2014-07-08

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