CranioXpand— 510(k) K230211

Substantially Equivalent

KLS-Martin L.P.

FDA 510(k) clearance K230211 for CranioXpand, Substantially Equivalent on 2023-11-21. Applicant: KLS-Martin L.P.. Device class: 2.

Clearance details

Applicant: KLS-Martin L.P.
Product code: Code PBJ
Device class: Class 2
Regulation: 21 CFR 882.5330
Advisory panel: Neurology
Date received: 2023-01-26
Decision date: 2023-11-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jacksonville, FL, US

Download summary PDF View on FDA.gov ↗

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