Tyber Medical Wedge System— 510(k) K150394

Substantially Equivalent

Tyber Medical, LLC

FDA 510(k) clearance K150394 for Tyber Medical Wedge System, Substantially Equivalent on 2015-07-28. Applicant: Tyber Medical, LLC. Device class: 2.

Clearance details

Applicant: Tyber Medical, LLC
Product code: Code PLF
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2015-02-18
Decision date: 2015-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Morristown, NJ, 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.