OSTEOMED SMARTFLEX CRANIAL SPRING DISTRACTOR— 510(k) K123885

Name: FDA 510(k) clearance K123885
Creator: U.S. Food and Drug Administration
Published: 2013-06-03

Substantially Equivalent

Osteomed LP

FDA 510(k) clearance K123885 for OSTEOMED SMARTFLEX CRANIAL SPRING DISTRACTOR, Substantially Equivalent on 2013-06-03. Applicant: Osteomed LP. Device class: 2.

Clearance details

Applicant: Osteomed LP
Product code: Code PBJ
Device class: Class 2
Regulation: 21 CFR 882.5330
Advisory panel: Neurology
Date received: 2012-12-18
Decision date: 2013-06-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Addison, TX, US

Download summary PDF View on FDA.gov ↗

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