Collagen Meniscus Implant XL— 510(k) K170364

Name: FDA 510(k) clearance K170364
Creator: U.S. Food and Drug Administration
Published: 2017-05-02

Substantially Equivalent

Ivy Sports Medicine, LLC

FDA 510(k) clearance K170364 for Collagen Meniscus Implant XL, Substantially Equivalent on 2017-05-02. Applicant: Ivy Sports Medicine, LLC. Device class: 2.

Clearance details

Applicant: Ivy Sports Medicine, LLC
Product code: Code OLC
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2017-02-06
Decision date: 2017-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redwood City, CA, US

Download summary PDF View on FDA.gov ↗

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