Striate+— 510(k) K201241

Substantially Equivalent

Orthocell, Ltd.

FDA 510(k) clearance K201241 for Striate+, Substantially Equivalent on 2021-01-11. Applicant: Orthocell, Ltd.. Device class: 2.

Clearance details

Applicant: Orthocell, Ltd.
Product code: Code NPL
Device class: Class 2
Regulation: 21 CFR 872.3930
Advisory panel: Dental
Date received: 2020-05-08
Decision date: 2021-01-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Perth, AU

Download summary PDF View on FDA.gov ↗

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