CoolTone— 510(k) K253408

Substantially Equivalent

Zimmer Medizinsysteme GmbH

FDA 510(k) clearance K253408 for CoolTone, Substantially Equivalent on 2026-01-16. Applicant: Zimmer Medizinsysteme GmbH.

Clearance details

Applicant: Zimmer Medizinsysteme GmbH
Product code: Code NGX
Advisory panel: Physical Medicine
Date received: 2025-09-30
Decision date: 2026-01-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Neu-Elm, DE

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