NextAR RSA Platform— 510(k) K210153

Substantially Equivalent

Medacta International S.A.

FDA 510(k) clearance K210153 for NextAR RSA Platform, Substantially Equivalent on 2021-05-12. Applicant: Medacta International S.A.. Device class: 2.

Clearance details

Applicant: Medacta International S.A.
Product code: Code SBF
Device class: Class 2
Regulation: 21 CFR 882.4560
Advisory panel: Neurology
Date received: 2021-01-21
Decision date: 2021-05-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Castel San Pietro (Ch), CH

Download summary PDF View on FDA.gov ↗

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Recalls naming K210153

K-number listed on FDA's recall record

Z-0372-2023 — NextAR Shoulder Surgical Technique, Shoulder NextAR RSA Platform, CT based computer-assisted surgical navigation platform used to perform a reverse shoulder arthroplasty on the glenoidClass II·Terminated·Medacta Usa Inc·20221027

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K210153.

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