OSTEOMED CRANIAL DISTRACTION SYSTEM— 510(k) K121304

Substantially Equivalent

Osteomed

FDA 510(k) clearance K121304 for OSTEOMED CRANIAL DISTRACTION SYSTEM, Substantially Equivalent on 2012-08-22. Applicant: Osteomed. Device class: 2.

Clearance details

Applicant: Osteomed
Product code: Code PBJ
Device class: Class 2
Regulation: 21 CFR 882.5330
Advisory panel: Neurology
Date received: 2012-05-01
Decision date: 2012-08-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Addison, TX, 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.