SP-LINK System— 510(k) K182352

Substantially Equivalent

Medical Designs, LLC

FDA 510(k) clearance K182352 for SP-LINK System, Substantially Equivalent on 2018-11-21. Applicant: Medical Designs, LLC. Device class: 2.

Clearance details

Applicant: Medical Designs, LLC
Product code: Code PEK
Device class: Class 2
Regulation: 21 CFR 888.3050
Advisory panel: Orthopedic
Date received: 2018-08-29
Decision date: 2018-11-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sioux Falls, SD, 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.